The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Contours Proimal Humeral Plate (php).
| Device ID | K122541 |
| 510k Number | K122541 |
| Device Name: | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | ORTHOFIX SRL 22423 SKYVIEW DRIVE West Linn, OR 97068 |
| Contact | Candace F Cederman |
| Correspondent | Candace F Cederman ORTHOFIX SRL 22423 SKYVIEW DRIVE West Linn, OR 97068 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-21 |
| Decision Date | 2012-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242510628 | K122541 | 000 |
| 18054242510390 | K122541 | 000 |
| 18054242510383 | K122541 | 000 |
| 18054242510376 | K122541 | 000 |
| 18054242510369 | K122541 | 000 |
| 18054242510352 | K122541 | 000 |
| 18054242510345 | K122541 | 000 |
| 18054242510338 | K122541 | 000 |
| 18054242510321 | K122541 | 000 |
| 18054242510314 | K122541 | 000 |
| 18054242510307 | K122541 | 000 |
| 18054242510291 | K122541 | 000 |
| 18054242510284 | K122541 | 000 |
| 18054242510277 | K122541 | 000 |
| 18054242510260 | K122541 | 000 |
| 18054242510253 | K122541 | 000 |
| 18054242510246 | K122541 | 000 |
| 18054242510239 | K122541 | 000 |
| 18054242510406 | K122541 | 000 |
| 18054242510413 | K122541 | 000 |
| 18054242510420 | K122541 | 000 |
| 18054242510611 | K122541 | 000 |
| 18054242510604 | K122541 | 000 |
| 18054242510598 | K122541 | 000 |
| 18054242510581 | K122541 | 000 |
| 18054242510574 | K122541 | 000 |
| 18054242510567 | K122541 | 000 |
| 18054242510550 | K122541 | 000 |
| 18054242510543 | K122541 | 000 |
| 18054242510536 | K122541 | 000 |
| 18054242510512 | K122541 | 000 |
| 18054242510499 | K122541 | 000 |
| 18054242510482 | K122541 | 000 |
| 18054242510475 | K122541 | 000 |
| 18054242510468 | K122541 | 000 |
| 18054242510451 | K122541 | 000 |
| 18054242510444 | K122541 | 000 |
| 18054242510437 | K122541 | 000 |
| 18054242510222 | K122541 | 000 |