The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peba Anchor/suture Combination, 2.0mm Mini-tac Anchor, Model 10-1629-01, Modification To Twinfix Ti Quick-t, Twinfix Ft Pk, Twinfix Ultra Ti, Twinfix Ultra Pk, Twinfix Ultra Ha Suture Anchors, Footprint Ultra Ok Suture Anchors, Bioraptor 2.9 Suture A.
| Device ID | K152566 |
| 510k Number | K152566 |
| Device Name: | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification To Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture A |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BOULEVARD Mansfield, MA 02048 |
| Contact | Katherine Marcaccio |
| Correspondent | Katherine Marcaccio SMITH & NEPHEW, INC. 130 FORBES BOULEVARD Mansfield, MA 02048 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-09 |
| Decision Date | 2015-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556885338 | K152566 | 000 |
| 00885556885321 | K152566 | 000 |
| 00885556885314 | K152566 | 000 |