The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Ultraslide Acromioclavicular And Syndesmotic Repair Device.
| Device ID | K082095 |
| 510k Number | K082095 |
| Device Name: | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE |
| Classification | Washer, Bolt Nut |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810 |
| Contact | Kathy Reddig |
| Correspondent | Kathy Reddig SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-24 |
| Decision Date | 2008-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010652898 | K082095 | 000 |