The following data is part of a premarket notification filed by Implantology Corp. with the FDA for Ufc Hip Stem Components: Hydroxylapatite Coated.
| Device ID | K934729 |
| 510k Number | K934729 |
| Device Name: | UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | IMPLANTOLOGY CORP. 11 OAK LN. Pine Brook, NJ 07058 |
| Contact | Mark R Forte |
| Correspondent | Mark R Forte IMPLANTOLOGY CORP. 11 OAK LN. Pine Brook, NJ 07058 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-07-22 |