The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Free Gliding Slipped Capital Femoral Epiphysis Screw (scfe).
| Device ID | K131591 |
| 510k Number | K131591 |
| Device Name: | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) |
| Classification | Screw, Fixation, Bone |
| Applicant | PEGA MEDICAL INC. 1111 AUTOROUTE CHOMEDEY Laval, CA H7w 5j8 |
| Contact | Ariel R Dujovne |
| Correspondent | Ariel R Dujovne PEGA MEDICAL INC. 1111 AUTOROUTE CHOMEDEY Laval, CA H7w 5j8 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540194002242 | K131591 | 000 |
| 07540194002365 | K131591 | 000 |
| 07540194002372 | K131591 | 000 |
| 07540194002389 | K131591 | 000 |
| 07540194002396 | K131591 | 000 |
| 07540194002402 | K131591 | 000 |
| 07540194002419 | K131591 | 000 |
| 07540194002426 | K131591 | 000 |
| 07540194002433 | K131591 | 000 |
| 07540194002358 | K131591 | 000 |
| 07540194002341 | K131591 | 000 |
| 07540194002334 | K131591 | 000 |
| 07540194002259 | K131591 | 000 |
| 07540194002266 | K131591 | 000 |
| 07540194002273 | K131591 | 000 |
| 07540194002280 | K131591 | 000 |
| 07540194002297 | K131591 | 000 |
| 07540194002303 | K131591 | 000 |
| 07540194002310 | K131591 | 000 |
| 07540194002327 | K131591 | 000 |
| 07540194002440 | K131591 | 000 |
| 07540194002457 | K131591 | 000 |
| 07540194002570 | K131591 | 000 |
| 07540194002587 | K131591 | 000 |
| 07540194002594 | K131591 | 000 |
| 07540194004291 | K131591 | 000 |
| 07540194004307 | K131591 | 000 |
| 07540194004369 | K131591 | 000 |
| 07540194004376 | K131591 | 000 |
| 07540194004451 | K131591 | 000 |
| 07540194002563 | K131591 | 000 |
| 07540194002556 | K131591 | 000 |
| 07540194002549 | K131591 | 000 |
| 07540194002464 | K131591 | 000 |
| 07540194002471 | K131591 | 000 |
| 07540194002488 | K131591 | 000 |
| 07540194002495 | K131591 | 000 |
| 07540194002501 | K131591 | 000 |
| 07540194002518 | K131591 | 000 |
| 07540194002525 | K131591 | 000 |
| 07540194002532 | K131591 | 000 |
| 07540194006011 | K131591 | 000 |