The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Km-5 Metal Backed Acetabular Cup.
| Device ID | K902279 |
| 510k Number | K902279 |
| Device Name: | KM-5 METAL BACKED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-22 |
| Decision Date | 1990-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304295377 | K902279 | 000 |
| 00880304293939 | K902279 | 000 |
| 00880304293946 | K902279 | 000 |
| 00880304295308 | K902279 | 000 |
| 00880304295315 | K902279 | 000 |
| 00880304295322 | K902279 | 000 |
| 00880304295339 | K902279 | 000 |
| 00880304295346 | K902279 | 000 |
| 00880304295353 | K902279 | 000 |
| 00880304295360 | K902279 | 000 |
| 00880304293908 | K902279 | 000 |