The following data is part of a premarket notification filed by Orthopediatrics, Llc with the FDA for Orthopediatrics Pediflex Flexible Nail System.
| Device ID | K081097 |
| 510k Number | K081097 |
| Device Name: | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | ORTHOPEDIATRICS, LLC 210 NORTH BUFFALO STREET Warsaw, IN 46580 |
| Contact | Gary Barnett |
| Correspondent | Gary Barnett ORTHOPEDIATRICS, LLC 210 NORTH BUFFALO STREET 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 | 2008-04-17 |
| Decision Date | 2008-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841132119655 | K081097 | 000 |
| 00841132119426 | K081097 | 000 |
| 00841132119419 | K081097 | 000 |
| 00841132119402 | K081097 | 000 |
| 00841132119396 | K081097 | 000 |
| 00841132119389 | K081097 | 000 |
| 00841132119372 | K081097 | 000 |
| 00841132119365 | K081097 | 000 |
| 00841132119358 | K081097 | 000 |
| 00841132145517 | K081097 | 000 |
| 00841132145500 | K081097 | 000 |
| 00841132145494 | K081097 | 000 |
| 00841132145487 | K081097 | 000 |
| 00841132145470 | K081097 | 000 |
| 00841132119433 | K081097 | 000 |
| 00841132119440 | K081097 | 000 |
| 00841132119457 | K081097 | 000 |
| 00841132119648 | K081097 | 000 |
| 00841132119631 | K081097 | 000 |
| 00841132119624 | K081097 | 000 |
| 00841132119617 | K081097 | 000 |
| 00841132119600 | K081097 | 000 |
| 00841132119594 | K081097 | 000 |
| 00841132119525 | K081097 | 000 |
| 00841132119518 | K081097 | 000 |
| 00841132119501 | K081097 | 000 |
| 00841132119495 | K081097 | 000 |
| 00841132119488 | K081097 | 000 |
| 00841132119471 | K081097 | 000 |
| 00841132119464 | K081097 | 000 |
| 00841132145463 | K081097 | 000 |