The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Acl Smart System.
| Device ID | K143172 |
| 510k Number | K143172 |
| Device Name: | ACL SMART System |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Samir Ibrahim |
| Correspondent | Samir Ibrahim SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-04 |
| Decision Date | 2015-02-04 |
| Summary: | summary |