The following data is part of a premarket notification filed by Newclip Technics with the FDA for Clavicle Locking Plate System.
| Device ID | K100944 |
| 510k Number | K100944 |
| Device Name: | CLAVICLE LOCKING PLATE 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 | 2010-04-06 |
| Decision Date | 2010-10-22 |
| Summary: | summary |