The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Vlp Mini-mod Talus Plates.
| Device ID | K152976 |
| 510k Number | K152976 |
| Device Name: | VLP Mini-Mod Talus Plates |
| Classification | Plate, Fixation, Bone |
| Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Contact | Samantha Staubach |
| Correspondent | Samantha Staubach Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-08 |
| Decision Date | 2015-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556581513 | K152976 | 000 |
| 00885556581360 | K152976 | 000 |
| 00885556581377 | K152976 | 000 |
| 00885556581384 | K152976 | 000 |
| 00885556581391 | K152976 | 000 |
| 00885556581407 | K152976 | 000 |
| 00885556581414 | K152976 | 000 |
| 00885556581421 | K152976 | 000 |
| 00885556581445 | K152976 | 000 |
| 00885556581452 | K152976 | 000 |
| 00885556581469 | K152976 | 000 |
| 00885556581476 | K152976 | 000 |
| 00885556581483 | K152976 | 000 |
| 00885556581490 | K152976 | 000 |
| 00885556581506 | K152976 | 000 |
| 00885556581353 | K152976 | 000 |