The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Guided Growth System Eight-plate, Quad-plate (stainless Steel).
| Device ID | K110805 |
| 510k Number | K110805 |
| Device Name: | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) |
| Classification | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Applicant | ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | OBT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2011-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242513513 | K110805 | 000 |
| 18054242513506 | K110805 | 000 |
| 18054242513490 | K110805 | 000 |
| 18054242513483 | K110805 | 000 |
| 18054242513476 | K110805 | 000 |
| 18054242513414 | K110805 | 000 |
| 18054242513407 | K110805 | 000 |
| 18054242513391 | K110805 | 000 |
| 18054242513384 | K110805 | 000 |