Chrysalis Intelligence · Sponsors · Neosteo

Neosteo

Nantes, FR · 2 510(k) clearances · 1 recalls

Total clearances
2
2020-02-28 → 2022-02-11
Last 12 months
0
Product codes
2
Most recent
2022-02-11
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 1 2022-02-11
JDR Staple, Fixation, Bone Class II Orthopedic 1 2020-02-28
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2020-11-03
DateSeverityStatusRecall # ProductCodeReason
2020-11-03 Class II Terminated Z-2236-2021 Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery. Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the o…
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-02-11 K212545 FlexitSystem Knee osteotomy system HRS Class II Orthopedic
2020-02-28 K192447 Superelastic Staple JDR Class II Orthopedic