The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Cannulated Screw.
| Device ID | K070617 |
| 510k Number | K070617 |
| Device Name: | CANNULATED SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimer, FR 29000 |
| Contact | Patricia Donnard |
| Correspondent | Patricia Donnard FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimer, FR 29000 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-05 |
| Decision Date | 2007-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489518270 | K070617 | 000 |
| 03661489518263 | K070617 | 000 |
| 03661489518256 | K070617 | 000 |
| 03661489518249 | K070617 | 000 |
| 03661489518232 | K070617 | 000 |
| 03661489518225 | K070617 | 000 |
| 03661489518218 | K070617 | 000 |