The following data is part of a premarket notification filed by Newclip Technics with the FDA for High Tibial Osteotomy System.
| Device ID | K141548 |
| 510k Number | K141548 |
| Device Name: | HIGH TIBIAL OSTEOTOMY SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-11 |
| Decision Date | 2015-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569602482 | K141548 | 000 |
| 03700569605339 | K141548 | 000 |
| 03700569605346 | K141548 | 000 |
| 03700569605353 | K141548 | 000 |
| 03700569605360 | K141548 | 000 |
| 03700569605377 | K141548 | 000 |
| 03700569605384 | K141548 | 000 |
| 03700569605391 | K141548 | 000 |
| 03700569605407 | K141548 | 000 |
| 03700569605414 | K141548 | 000 |
| 03700569602468 | K141548 | 000 |
| 03700569605322 | K141548 | 000 |