The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Twistcut Snap-off Bone Screw.
| Device ID | K051323 |
| 510k Number | K051323 |
| Device Name: | MERETE TWISTCUT SNAP-OFF BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York, NY 10023 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York, NY 10023 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266038265 | K051323 | 000 |
| 04048266038258 | K051323 | 000 |
| 04048266038241 | K051323 | 000 |
| 04048266038272 | K051323 | 000 |