The following data is part of a premarket notification filed by Merete Medical, Inc. with the FDA for Merete Locking Bone Plate System.
| Device ID | K090063 |
| 510k Number | K090063 |
| Device Name: | MERETE LOCKING BONE PLATE SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | MERETE MEDICAL, INC. 49 PURCHASE ST. Rye, NY 10580 |
| Contact | Jorg Mietzner |
| Correspondent | Jorg Mietzner MERETE MEDICAL, INC. 49 PURCHASE ST. Rye, NY 10580 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-09 |
| Decision Date | 2009-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841742122359 | K090063 | 000 |
| 04048266076953 | K090063 | 000 |
| 04048266076946 | K090063 | 000 |
| 04048266077059 | K090063 | 000 |
| 04048266077042 | K090063 | 000 |
| 04048266077035 | K090063 | 000 |
| 04048266077028 | K090063 | 000 |
| 04048266077004 | K090063 | 000 |
| 04048266076977 | K090063 | 000 |
| 04048266076328 | K090063 | 000 |
| 04048266076311 | K090063 | 000 |
| 04048266076250 | K090063 | 000 |
| 04048266076960 | K090063 | 000 |
| 04048266076984 | K090063 | 000 |
| 00841742122342 | K090063 | 000 |
| 00841742122335 | K090063 | 000 |
| 00841742122328 | K090063 | 000 |
| 04048266076298 | K090063 | 000 |
| 04048266076281 | K090063 | 000 |
| 04048266076274 | K090063 | 000 |
| 04048266076229 | K090063 | 000 |
| 04048266076212 | K090063 | 000 |
| 04048266076205 | K090063 | 000 |
| 04048266077011 | K090063 | 000 |
| 04048266076991 | K090063 | 000 |
| 04048266076243 | K090063 | 000 |