The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete 3.0 And 3.5 Mm Locking Screws.
| Device ID | K081513 |
| 510k Number | K081513 |
| Device Name: | MERETE 3.0 AND 3.5 MM LOCKING SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Contact | Jorg Mietzner |
| Correspondent | Jorg Mietzner MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-30 |
| Decision Date | 2008-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266024688 | K081513 | 000 |
| 04048266024626 | K081513 | 000 |
| 04048266024640 | K081513 | 000 |
| 04048266024701 | K081513 | 000 |
| 04048266024657 | K081513 | 000 |
| 04048266024671 | K081513 | 000 |
| 04048266024695 | K081513 | 000 |
| 04048266024619 | K081513 | 000 |
| 04048266024633 | K081513 | 000 |
| 04048266024664 | K081513 | 000 |
| 04048266024602 | K081513 | 000 |