The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Modular Femoral Head With Offset Trunion.
| Device ID | K914675 |
| 510k Number | K914675 |
| Device Name: | MODULAR FEMORAL HEAD WITH OFFSET TRUNION |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1992-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304256224 | K914675 | 000 |
| 00880304256217 | K914675 | 000 |
| 00880304256200 | K914675 | 000 |
| 00880304256194 | K914675 | 000 |
| 00880304256187 | K914675 | 000 |
| 00880304255418 | K914675 | 000 |
| 00880304255395 | K914675 | 000 |
| 00880304255388 | K914675 | 000 |
| 00880304007550 | K914675 | 000 |