The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Intrinsic Stem.
| Device ID | K923911 |
| 510k Number | K923911 |
| Device Name: | INTRINSIC STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Contact | Jerry Keyes |
| Correspondent | Jerry Keyes TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1993-04-14 |