The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Kar.
| Device ID | K961732 |
| 510k Number | K961732 |
| Device Name: | KAR |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-03 |
| Decision Date | 1997-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295260684 | K961732 | 000 |
| 10603295260677 | K961732 | 000 |
| 10603295260660 | K961732 | 000 |