The following data is part of a premarket notification filed by In2bones Sas with the FDA for I.b.s Snap-off Screw / Solafix Snap-off Screw.
| Device ID | K132911 |
| 510k Number | K132911 |
| Device Name: | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | IN2BONES SAS 28 CHEMIN DU PETIT BOIS 69130 ECULLY France, FR 69130 |
| Contact | Eric Fourcault |
| Correspondent | Eric Fourcault IN2BONES SAS 28 CHEMIN DU PETIT BOIS 69130 ECULLY France, FR 69130 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-17 |
| Decision Date | 2014-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701337605513 | K132911 | 000 |
| 03760225712627 | K132911 | 000 |
| 03760225712610 | K132911 | 000 |
| 03760225712603 | K132911 | 000 |
| 03760225712597 | K132911 | 000 |
| 03760225712252 | K132911 | 000 |
| 03760225712245 | K132911 | 000 |
| 03760225712238 | K132911 | 000 |
| 03760225712221 | K132911 | 000 |
| 03760225710081 | K132911 | 000 |
| 03760225710074 | K132911 | 000 |
| 03760225710067 | K132911 | 000 |
| 03760225712634 | K132911 | 000 |
| 03701337605285 | K132911 | 000 |
| 03701337605506 | K132911 | 000 |
| 03701337605490 | K132911 | 000 |
| 03701337605483 | K132911 | 000 |
| 03701337605476 | K132911 | 000 |
| 03701337605469 | K132911 | 000 |
| 03701337605452 | K132911 | 000 |
| 03701337605339 | K132911 | 000 |
| 03701337605322 | K132911 | 000 |
| 03701337605315 | K132911 | 000 |
| 03701337605308 | K132911 | 000 |
| 03701337605292 | K132911 | 000 |
| 03760225710050 | K132911 | 000 |