The following data is part of a premarket notification filed by Biomet Trauma with the FDA for Growth Control Plating System.
| Device ID | K070823 |
| 510k Number | K070823 |
| Device Name: | GROWTH CONTROL PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET TRAUMA 100 INTERFACE PARKWAY Parsippany, NJ 07054 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET TRAUMA 100 INTERFACE PARKWAY Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304500433 | K070823 | 000 |
| 00888480237310 | K070823 | 000 |
| 00888480237327 | K070823 | 000 |
| 00888480237334 | K070823 | 000 |
| 00880304491526 | K070823 | 000 |
| 00880304492530 | K070823 | 000 |
| 00880304532373 | K070823 | 000 |
| 00880304491571 | K070823 | 000 |
| 00880304500402 | K070823 | 000 |
| 00880304500419 | K070823 | 000 |
| 00880304500426 | K070823 | 000 |
| 00888480237303 | K070823 | 000 |