The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Healicoil Pk Suture Anchor.
| Device ID | K113294 |
| 510k Number | K113294 |
| Device Name: | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Elizabeth Lavelle |
| Correspondent | Elizabeth Lavelle SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2012-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554032130 | K113294 | 000 |
| 00885554032123 | K113294 | 000 |
| 00885554032116 | K113294 | 000 |
| 00885554032109 | K113294 | 000 |
| 00885554026313 | K113294 | 000 |
| 00885554026306 | K113294 | 000 |
| 03596010657862 | K113294 | 000 |