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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569660161 | K172596 | 000 |
| 03700569632427 | K172596 | 000 |
| 03700569632366 | K172596 | 000 |
| 03700569632304 | K172596 | 000 |
| 03700569626938 | K172596 | 000 |
| 03700569626907 | K172596 | 000 |
| 03700569615024 | K172596 | 000 |
| 03700569615017 | K172596 | 000 |
| 03700569615000 | K172596 | 000 |
| 03700569614997 | K172596 | 000 |
| 03700569614973 | K172596 | 000 |
| 03700569614966 | K172596 | 000 |
| 03700569614942 | K172596 | 000 |
| 03700569614935 | K172596 | 000 |
| 03700569614911 | K172596 | 000 |
| 03700569614904 | K172596 | 000 |
| 03700569614898 | K172596 | 000 |
| 03700569632557 | K172596 | 000 |
| 03700569632618 | K172596 | 000 |
| 03700569660154 | K172596 | 000 |
| 03700569660147 | K172596 | 000 |
| 03700569660130 | K172596 | 000 |
| 03700569660123 | K172596 | 000 |
| 03700569660116 | K172596 | 000 |
| 03700569660109 | K172596 | 000 |
| 03700569660093 | K172596 | 000 |
| 03700569660086 | K172596 | 000 |
| 03700569660079 | K172596 | 000 |
| 03700569660062 | K172596 | 000 |
| 03700569660055 | K172596 | 000 |
| 03700569660048 | K172596 | 000 |
| 03700569660031 | K172596 | 000 |
| 03700569660024 | K172596 | 000 |
| 03700569634476 | K172596 | 000 |
| 03700569634278 | K172596 | 000 |
| 03700569614867 | K172596 | 000 |