The following data is part of a premarket notification filed by Theken Companies, Llc with the FDA for Insitu Total Hip System.
| Device ID | K192071 |
| 510k Number | K192071 |
| Device Name: | INSitu Total Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Theken Companies, LLC 1800 Triplett Blvd Akron, OH 44306 |
| Contact | Garrett Spurgeon |
| Correspondent | Robert A. Poggie BioVera, Inc. 65 Promenade Saint Louis Notre Dame De L'lle Perrot, CA J7v7p2 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-02 |
| Decision Date | 2019-08-30 |