The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Hinge Pediatric Plating System.
| Device ID | K090440 |
| 510k Number | K090440 |
| Device Name: | HINGE PEDIATRIC PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | PEGA MEDICAL INC. 1105 AUTOROUTE CHOMEDEY Laval, Quebec, CA H7w 5j8 |
| Contact | Ariel Dujovne |
| Correspondent | Ariel Dujovne PEGA MEDICAL INC. 1105 AUTOROUTE CHOMEDEY Laval, Quebec, CA H7w 5j8 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-20 |
| Decision Date | 2009-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540194004338 | K090440 | 000 |
| 07540194000576 | K090440 | 000 |
| 07540194000583 | K090440 | 000 |
| 07540194000590 | K090440 | 000 |
| 07540194000606 | K090440 | 000 |
| 07540194000613 | K090440 | 000 |
| 07540194000620 | K090440 | 000 |
| 07540194000637 | K090440 | 000 |
| 07540194000644 | K090440 | 000 |
| 07540194000651 | K090440 | 000 |
| 07540194000668 | K090440 | 000 |
| 07540194000675 | K090440 | 000 |
| 07540194000682 | K090440 | 000 |
| 07540194000699 | K090440 | 000 |
| 07540194000705 | K090440 | 000 |
| 07540194004314 | K090440 | 000 |
| 07540194004321 | K090440 | 000 |
| 07540194000569 | K090440 | 000 |