The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Vlp Mini-mod 2.0mm Column Plates.
| Device ID | K163086 |
| 510k Number | K163086 |
| Device Name: | VLP MINI-MOD 2.0mm Column Plates |
| Classification | Plate, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD Memphis, TN 38116 |
| Contact | Samantha Staubach |
| Correspondent | Samantha Staubach SMITH & NEPHEW, INC. 1450 BROOKS RD Memphis, TN 38116 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2016-12-21 |
| Summary: | summary |