The following data is part of a premarket notification filed by Newclip Technics with the FDA for Large Screws Range.
| Device ID | K172596 |
| 510k Number | K172596 |
| Device Name: | Large Screws Range |
| Classification | Screw, Fixation, Bone |
| Applicant | Newclip Technics PA De La Lande Saint Martin - 45 Rue Des Garottieres Haute-goulaine, FR 44 115 |
| Contact | Gaelle Lussori |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-29 |
| Decision Date | 2017-10-02 |
| Summary: | summary |