The following data is part of a premarket notification filed by Theken Companies, Llc with the FDA for Insitu Bipolar Hip System.
| Device ID | K191297 |
| 510k Number | K191297 |
| Device Name: | INSitu Bipolar Hip System |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Theken Companies, LLC 1800 Triplett Blvd Akron, OH 44306 |
| Contact | Garrett Spurgeon |
| Correspondent | Bob Poggie BioVera 65 Promenade Saint-Louis Notre-dame-de-l'lle-perrot, CA J7v 7p2 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-14 |
| Decision Date | 2019-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816127029998 | K191297 | 000 |
| 00816127029530 | K191297 | 000 |
| 00816127029523 | K191297 | 000 |
| 00816127029516 | K191297 | 000 |
| 00816127029509 | K191297 | 000 |
| 00816127029493 | K191297 | 000 |
| 00816127029486 | K191297 | 000 |
| 00816127029479 | K191297 | 000 |
| 00816127029462 | K191297 | 000 |
| 00816127029455 | K191297 | 000 |
| 00816127029448 | K191297 | 000 |
| 00816127029547 | K191297 | 000 |
| 00816127029554 | K191297 | 000 |
| 00816127029561 | K191297 | 000 |
| 00816127029981 | K191297 | 000 |
| 00816127029974 | K191297 | 000 |
| 00816127029967 | K191297 | 000 |
| 00816127029950 | K191297 | 000 |
| 00816127029943 | K191297 | 000 |
| 00816127029936 | K191297 | 000 |
| 00816127029929 | K191297 | 000 |
| 00816127029912 | K191297 | 000 |
| 00816127029905 | K191297 | 000 |
| 00816127029899 | K191297 | 000 |
| 00816127029431 | K191297 | 000 |