The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Headloc Ceramic Femoral Heads.
| Device ID | K971435 |
| 510k Number | K971435 |
| Device Name: | HEADLOC CERAMIC FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Contact | Carol J Freasier |
| Correspondent | Carol J Freasier ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-18 |
| Decision Date | 1997-07-09 |