The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Twistcut Endosorb Screws.
| Device ID | K102777 |
| 510k Number | K102777 |
| Device Name: | TWISTCUT ENDOSORB SCREWS |
| Classification | Pin, Fixation, Threaded |
| Applicant | MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2010-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266010322 | K102777 | 000 |