Smith & Nephew, Inc. · Class II · Cleared Dec 2, 2015
| K-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 Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors |
| Applicant | Smith & Nephew, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Dec 2, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
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