Chrysalis Intelligence · Sponsors · Depuy Spine

Depuy Spine

Raynham, MA, US · 2 510(k) clearances · 2 recalls

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Total clearances
2
2020-08-31 → 2022-10-15
Last 12 months
0
Product codes
2
Most recent
2022-10-15
Name variants in FDA filings: Depuy Spine, Inc. / Depuy Spine
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 1 2022-10-15
NDN Cement, Bone, Vertebroplasty Class II Orthopedic 1 2020-08-31
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2022-05-20
DateSeverityStatusRecall # ProductCodeReason
2022-05-20 Class II Ongoing Z-1324-2022 EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an … — Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be corre…
2022-05-20 Class II Ongoing Z-1323-2022 EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an … — Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be corre…
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-10-15 K222276 CONDUIT Cages; FIBERGRAFT BG Putty ODP Class II Orthopedic
2020-08-31 K201831 CONFIDENCE Spinal Cement System NDN Class II Orthopedic
Data source: openFDA · Generated 2026-08-12 09:28 · Last ingest 2026-08-12T13:28:53.594808 · Pipeline: Chrysalis Intelligence