The following data is part of a premarket notification filed by Osteo-technology Intl., Inc. with the FDA for Replica Total Hip System.
| Device ID | K951741 |
| 510k Number | K951741 |
| Device Name: | REPLICA TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OSTEO-TECHNOLOGY INTL., INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Contact | John A Roberts |
| Correspondent | John A Roberts OSTEO-TECHNOLOGY INTL., INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-31 |
| Decision Date | 1995-08-07 |