Chrysalis Intelligence · Sponsors · Integrity Implants, Inc.

Integrity Implants, Inc.

Palm Beach Gardens, FL, US · 8 510(k) clearances · 5 recalls

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Total clearances
8
2020-09-23 → 2023-08-07
Last 12 months
0
Product codes
3
Most recent
2023-08-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 5 2022-03-25
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 2 2023-08-07
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2021-12-23
Safety

Recalls (5)

Class I (serious)
0
Risk of injury / death
Total recalls
5
Currently ongoing
1
Most recent
2024-12-20
DateSeverityStatusRecall # ProductCodeReason
2024-12-20 Class II Ongoing Z-1008-2025 Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descr… — Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
2022-08-03 Class II Terminated Z-0421-2023 LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N… — Potential for intraoperative screw head separation at weld location.
2022-01-27 Class II Terminated Z-0420-2023 LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; … — Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from…
2022-01-27 Class II Terminated Z-0419-2023 LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw sys… — Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from…
2022-01-27 Class II Terminated Z-0418-2023 LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw… — Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from…
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2023-08-07 K231098 LineSider® Spinal System NKB Class II Orthopedic
2022-03-25 K213355 Toro-L Interbody Fusion System MAX Class II Orthopedic
2022-03-24 K220453 FlareHawk Interbody Fusion System MAX Class II Orthopedic
2021-12-23 K212088 Integrity Implants Navigated Instruments OLO Class II Neurology
2021-03-26 K203038 Toro-L Interbody Fusion System MAX Class II Orthopedic
2020-12-03 K203367 LineSider™ Spinal System NKB Class II Orthopedic
2020-11-03 K202198 FlareHawk Interbody Fusion System MAX Class II Orthopedic
2020-09-23 K201367 FlareHawk TiHawk9 Interbody Fusion System MAX Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence