FDA device listing
BIORAPTOR 2.9mm Suture Anchor with one 38” ULTRABRAID Co-Braid Suture (#2),BIORAPTOR 2.9mm Suture Anchor with two 38”…
FDA device listing 1021615067 · Smith & Nephew, Inc.
Key facts
| Proprietary names | BIORAPTOR 2.9mm Suture Anchor with one 38” ULTRABRAID Co-Braid Suture (#2),BIORAPTOR 2.9mm Suture Anchor with two 38” DURABRAID Sutures (USP#2),BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures (#2),BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures and Needles,HEALICOIL REGENESORB 4.75mm Suture Anchor with two ULTRABRAID (#2) sutures (blue/cobraid blue),HEALICOIL REGENESORB… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K151105 |
| Product codes | GAT, HWC, JDR, MAI, MBI |
| Device names | GAT - Suture, Nonabsorbable, Synthetic, Polyethylene, HWC - Screw, Fixation, Bone, JDR - Staple, Fixation, Bone, MAI - Fastener, Fixation, Biodegradable, Soft Tissue, MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.5000, 888.3030, 888.3040 |
| Review panels | General & Plastic Surgery, Orthopedic |
| Registered establishments | Arthrocare Corporation, SMITH & NEPHEW INC. |
| Establishment registrations | 1219602, 3003604053, 3012358417 |
| FEI numbers | 1219602, 3003604053, 3012358417 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database