The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Tls Fixation System.
| Device ID | K080974 |
| 510k Number | K080974 |
| Device Name: | TLS FIXATION SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Contact | Patricia Donnard |
| Correspondent | Patricia Donnard FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-04 |
| Decision Date | 2008-07-01 |
| Summary: | summary |