Chrysalis Intelligence · Sponsors · In2bones Sas

In2bones Sas

Ecully, FR · 4 510(k) clearances · 3 recalls

Total clearances
4
2020-01-29 → 2024-04-23
Last 12 months
0
Product codes
1
Most recent
2024-04-23
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HSN 4 2024-04-23
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
2
Most recent
2024-01-26
DateSeverityStatusRecall # ProductCodeReason
2024-01-26 Class II Ongoing Z-1320-2024 I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compre…
2024-01-26 Class II Ongoing Z-1319-2024 I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compre…
2021-02-09 Class II Terminated Z-1283-2021 In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery. This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possi…
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-04-23 K231699 QUANTUM® Patient Specific Instrumentation (PSI) System HSN
2023-04-06 K230313 QUANTUM Patient Specific Instrumentation (PSI) System HSN
2021-08-11 K211883 QUANTUM® Patient Specific Instrumentation (PSI) System HSN
2020-01-29 K191380 Quantum® Total Ankle Prosthesis HSN