The following data is part of a premarket notification filed by Praxim Medivision, Sa with the FDA for Total Knee Surgetics Navigation System With Iblock.
| Device ID | K090953 |
| 510k Number | K090953 |
| Device Name: | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | PRAXIM MEDIVISION, SA LE GRAND SABLON 4 AVENUE DE L'OBIOU La Tronche, FR 38700 |
| Contact | Sebastien Burtin |
| Correspondent | Sebastien Burtin PRAXIM MEDIVISION, SA LE GRAND SABLON 4 AVENUE DE L'OBIOU La Tronche, FR 38700 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-03 |
| Decision Date | 2010-01-21 |
| Summary: | summary |