The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Guided Growth Plate System Plus.
| Device ID | K180624 |
| 510k Number | K180624 |
| Device Name: | Guided Growth Plate System Plus |
| Classification | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Applicant | Orthofix Srl Via Delle Nazioni 9 Bussolengo, IT 37012 |
| Contact | Gianluca Ricadona |
| Correspondent | Gianluca Ricadona Wagoner Consulting LLC Via Delle Nazioni 9 Bussolengo, IT 37012 |
| Product Code | OBT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-09 |
| Decision Date | 2018-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242518396 | K180624 | 000 |
| 18054242518389 | K180624 | 000 |
| 18054242518372 | K180624 | 000 |
| 18054242518242 | K180624 | 000 |
| 18054242518235 | K180624 | 000 |
| 18054242518228 | K180624 | 000 |