The following data is part of a premarket notification filed by Newclip Technics with the FDA for Alians Ulna Locking Plating System.
| Device ID | K142502 |
| 510k Number | K142502 |
| Device Name: | ALIANS ULNA LOCKING PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWCLIP TECHNICS PA De La Lande Saint Martin – 45 Rue Des Garottières Haute-goulaine, FR 44115 |
| Contact | Gaëlle Lussori |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc. 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 | 2014-09-05 |
| Decision Date | 2014-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569608446 | K142502 | 000 |
| 03700569604240 | K142502 | 000 |
| 03700569604264 | K142502 | 000 |
| 03700569604288 | K142502 | 000 |
| 03700569604301 | K142502 | 000 |
| 03700569604325 | K142502 | 000 |
| 03700569604349 | K142502 | 000 |
| 03700569604363 | K142502 | 000 |
| 03700569604387 | K142502 | 000 |
| 03700569604226 | K142502 | 000 |