The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Km-4(tm) Metal-backed Acetabular Cup.
| Device ID | K870867 |
| 510k Number | K870867 |
| Device Name: | KM-4(TM) METAL-BACKED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| 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 | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304287693 | K870867 | 000 |
| 00880304287679 | K870867 | 000 |