Chrysalis Intelligence · Sponsors · Teknimed Sas

Teknimed Sas

L'Union, FR · 1 510(k) clearances · 1 recalls

Total clearances
1
2024-12-18 → 2024-12-18
Last 12 months
0
Product codes
1
Most recent
2024-12-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MBB Bone Cement, Antibiotic Class II Orthopedic 1 2024-12-18
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2022-12-15
DateSeverityStatusRecall # ProductCodeReason
2022-12-15 Class II Ongoing Z-1099-2023 HIGH V+ Spinal Cement System REF T040321K Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2024-12-18 K242216 GENTAFIX® (1, 3, 3MV) MBB Class II Orthopedic