The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Toemobile Anatomical Great Toe Resurfacing System.
| Device ID | K072251 |
| 510k Number | K072251 |
| Device Name: | MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Contact | Donna Coleman |
| Correspondent | Donna Coleman MERETE MEDICAL GMBH 49 PURCHASE STREET Rye, NY 10580 |
| Product Code | LZJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-13 |
| Decision Date | 2008-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266047304 | K072251 | 000 |
| 04048266000958 | K072251 | 000 |
| 04048266000965 | K072251 | 000 |
| 04048266000972 | K072251 | 000 |
| 04048266047229 | K072251 | 000 |
| 04048266047236 | K072251 | 000 |
| 04048266047243 | K072251 | 000 |
| 04048266047250 | K072251 | 000 |
| 04048266047267 | K072251 | 000 |
| 04048266047274 | K072251 | 000 |
| 04048266047281 | K072251 | 000 |
| 04048266047298 | K072251 | 000 |
| 04048266000941 | K072251 | 000 |