The following data is part of a premarket notification filed by In2bones Sas with the FDA for Duafit Intergphalangeal Implant, Peek-fuse Interphalangeal Implant.
| Device ID | K132912 |
| 510k Number | K132912 |
| Device Name: | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT |
| Classification | Screw, Fixation, Bone |
| Applicant | IN2BONES SAS 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin, Ph.d. |
| Correspondent | Norman F Estrin, Ph.d. IN2BONES SAS 9109 COPENHAVER DR. Potomac, MD 20854 |
| 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 | 2014-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701337603137 | K132912 | 000 |
| 03701337603014 | K132912 | 000 |
| 03701337603021 | K132912 | 000 |
| 03701337603038 | K132912 | 000 |
| 03701337603069 | K132912 | 000 |
| 03701337603076 | K132912 | 000 |
| 03701337603083 | K132912 | 000 |
| 03701337603090 | K132912 | 000 |
| 03701337603106 | K132912 | 000 |
| 03701337603113 | K132912 | 000 |
| 03701337603120 | K132912 | 000 |
| 03701337603007 | K132912 | 000 |