The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Guided Growth System.
| Device ID | K093442 |
| 510k Number | K093442 |
| Device Name: | GUIDED GROWTH SYSTEM |
| Classification | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Applicant | ORTHOFIX INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers ORTHOFIX INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Product Code | OBT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-05 |
| Decision Date | 2010-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242518464 | K093442 | 000 |
| 18054242513360 | K093442 | 000 |
| 18054242513377 | K093442 | 000 |
| 18054242518075 | K093442 | 000 |
| 18054242518082 | K093442 | 000 |
| 18054242518099 | K093442 | 000 |
| 18054242518327 | K093442 | 000 |
| 18054242518334 | K093442 | 000 |
| 18054242518341 | K093442 | 000 |
| 18054242518358 | K093442 | 000 |
| 18054242518365 | K093442 | 000 |
| 18054242518402 | K093442 | 000 |
| 18054242518419 | K093442 | 000 |
| 18054242518426 | K093442 | 000 |
| 18054242518433 | K093442 | 000 |
| 18054242518440 | K093442 | 000 |
| 18054242518457 | K093442 | 000 |
| 18053504367277 | K093442 | 000 |