FDA device listing
HEALICOIL Knotless PK Suture Anchor, 5.0mm,HEALICOIL Knotless PK Suture Anchor, 5.0mm, Self-Tapping,HEALICOIL Knotless…
FDA device listing 1426028258 · Smith & Nephew, Inc.
Key facts
| Proprietary names | HEALICOIL Knotless PK Suture Anchor, 5.0mm,HEALICOIL Knotless PK Suture Anchor, 5.0mm, Self-Tapping,HEALICOIL Knotless REGENESORB Suture Anchor, 5.5mm,HEALICOIL Knotless REGENESORB Suture Anchor, 5.5mm, Self-Tapping,HEILICOIL Knotless Drill, 4.75mm |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K193558 |
| Product codes | MAI, MBI |
| Device names | MAI - Fastener, Fixation, Biodegradable, Soft Tissue, MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 888.3040 |
| Review panels | 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