FDA device listing
Dilator, HEALICOIL REGENESORB 5.5mm, Disposable, 72203952,HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE…
FDA device listing 1434940946 · Smith & Nephew, Inc.
Key facts
| Proprietary names | Dilator, HEALICOIL REGENESORB 5.5mm, Disposable, 72203952,HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE COBRAID BLUE AND ONE ULTRABRAID SUTURE No.2,HEALICOIL REGENESORB 4.75mm Suture Anchor with Two ULTRABRAID (#2) Sutures (Blue/Cobraid Blue),HEALICOIL REGENESORB 4.75 MM THREADED DILATOR, DISPOSABLE,HEALICOIL REGENESORB 4.75 MM THREADED DILATOR, REUSABLE,HEALICOIL REGENESORB… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K123393 |
| Product codes | MAI |
| Device names | MAI - Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| Review panels | Orthopedic |
| Registered establishments | Arthrocare Corporation, SMITH & NEPHEW INC. |
| Establishment registrations | 1219602, 1643264, 3003604053, 3012358417 |
| FEI numbers | 1219602, 1643264, 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