The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Pediflex Flexible Nail System.
| Device ID | K082375 |
| 510k Number | K082375 |
| Device Name: | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw, IN 46580 |
| Contact | Gary Barnett |
| Correspondent | Gary Barnett ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw, IN 46580 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2008-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841132119716 | K082375 | 000 |
| 00841132119532 | K082375 | 000 |
| 00841132145623 | K082375 | 000 |
| 00841132145616 | K082375 | 000 |
| 00841132145609 | K082375 | 000 |
| 00841132145593 | K082375 | 000 |
| 00841132145586 | K082375 | 000 |
| 00841132145579 | K082375 | 000 |
| 00841132145562 | K082375 | 000 |
| 00841132119549 | K082375 | 000 |
| 00841132119556 | K082375 | 000 |
| 00841132119709 | K082375 | 000 |
| 00841132119693 | K082375 | 000 |
| 00841132119686 | K082375 | 000 |
| 00841132119679 | K082375 | 000 |
| 00841132119662 | K082375 | 000 |
| 00841132119587 | K082375 | 000 |
| 00841132119570 | K082375 | 000 |
| 00841132119563 | K082375 | 000 |
| 00841132100080 | K082375 | 000 |