Freiburg, DE · 16 510(k) clearances · 25 PMAs · 5 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 8 | 2026-02-19 |
| JEY | Plate, Bone | Class II | Dental | 3 | 2024-07-12 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 2 | 2026-07-01 |
| FWP | — | — | — | 1 | 2026-03-12 |
| DZL | Screw, Fixation, Intraosseous | Class II | Dental | 1 | 2023-08-24 |
| HBW | — | — | — | 1 | 2023-08-14 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-07-15 | P130014-S022 | Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant | Panel Track | NQR | — | — |
| 2026-03-06 | P980052-S017 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | 135 Review Track For 30-Day Notice | LZD | — | — |
| 2025-11-06 | P130014-S021 | Adherus AutoSpray Dural Sealant | 135 Review Track For 30-Day Notice | NQR | — | — |
| 2025-07-23 | P980052-S016 | TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System | Special (Immediate Track) | LZD | — | — |
| 2024-08-29 | P130014-S020 | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2024-08-08 | P980052-S015 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | 30-Day Notice | LZD | — | — |
| 2024-07-30 | P980052-S014 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | 30-Day Notice | LZD | — | — |
| 2023-10-07 | P130014-S019 | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2023-08-25 | P130014-S018 | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2023-08-22 | P980052-S012 | TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st | 30-Day Notice | LZD | — | — |
| 2023-04-05 | P130014-S017 | Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant | 30-Day Notice | NQR | — | — |
| 2023-01-05 | P130014-S016 | Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant | 30-Day Notice | NQR | — | — |
| 2022-08-31 | P980052-S011 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | 30-Day Notice | LZD | — | — |
| 2022-03-16 | P130014-S015 | Adherus ET AutoSpray Dural Sealant, NUS-109 | 30-Day Notice | NQR | — | — |
| 2022-02-14 | P130014-S014 | Adherus AutoSpray Dural Sealant, NUS-106 | 30-Day Notice | NQR | — | — |
| 2021-12-17 | P130014-S013 | Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant | 30-Day Notice | NQR | — | — |
| 2021-09-15 | P130014-S012 | Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2021-04-27 | P980052-S009 | Patient-Fitted TMJ Reconstruction Prosthesis System | Normal 180 Day Track No User Fee | LZD | — | — |
| 2021-04-16 | P130014-S011 | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2021-03-05 | P130014-S010 | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2020-12-01 | P130014-S009 | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2020-11-24 | P980052-S008 | Patient-Fitted TMJ Reconstruction Prosthesis System | 30-Day Notice | LZD | — | — |
| 2020-08-14 | P130014-S008 | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant | 30-Day Notice | NQR | — | — |
| 2020-07-10 | P130014-S007 | Adherus AutoSpray ET Dural Sealant | Real-Time Process | NQR | — | — |
| 2020-01-10 | P980052-S007 | Patient-Fitted TMJ Reconstruction Prosthesis System | Normal 180 Day Track No User Fee | LZD | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-04-04 | Class II | Ongoing | Z-1885-2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution… | — | Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference po… |
| 2024-03-29 | Class II | Ongoing | Z-1785-2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony… | — | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure |
| 2022-12-06 | Class II | Ongoing | Z-1234-2023 | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis | — | Device was shipped without having regulatory approval. |
| 2021-12-29 | Class II | Terminated | Z-0715-2022 | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | — | Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of… |
| 2021-04-01 | Class II | Terminated | Z-1436-2021 | DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-… | — | Inability for the user to inject the paste from the syringe into the target location. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-01 | K261054 | RibPlate System | HRS | Class II | Orthopedic |
| 2026-03-12 | K254233 | MEDPOR Customized Implant Kit | FWP | — | — |
| 2026-02-19 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | OLO | Class II | Neurology |
| 2026-02-06 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | OLO | Class II | Neurology |
| 2024-12-11 | K243491 | SternalPlate Expansion | HRS | Class II | Orthopedic |
| 2024-08-27 | K241517 | Q Guidance System; Mako Spine System; | OLO | Class II | Neurology |
| 2024-07-25 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | OLO | Class II | Neurology |
| 2024-07-12 | K240651 | MRI Universal | JEY | Class II | Dental |
| 2024-06-06 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece | OLO | Class II | Neurology |
| 2024-03-14 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | OLO | Class II | Neurology |
| 2023-08-24 | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | DZL | Class II | Dental |
| 2023-08-14 | K231208 | Stryker Resorbable Fixation System | HBW | — | — |
| 2023-08-05 | K230733 | Stryker Resorbable Fixation System | JEY | Class II | Dental |
| 2023-02-13 | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | OLO | Class II | Neurology |
| 2022-11-09 | K221855 | Universal CMF System | JEY | Class II | Dental |
| 2022-05-27 | K220593 | Spine Guidance Software, Stryker Q Guidance System | OLO | Class II | Neurology |