FDA device listing
135 mm Reusable Slat, SE Retr, 10 Pack,155 mm Reusable Slat, SE Retr, 10 Pack,175mm Reusable Slat, SE Retr, 10…
FDA device listing 1306061146 · STRYKER CORP.
Key facts
| Proprietary names | 135 mm Reusable Slat, SE Retr, 10 Pack,155 mm Reusable Slat, SE Retr, 10 Pack,175mm Reusable Slat, SE Retr, 10 Pack,234-112-100 VersiQuad Halo Retractor,90 mm Reusable Slat, SE Retr, 10 Pack,Aequalis Instrument,AEQUALIS RESURFACING HEAD,Aequalis Retractor Shoulder System,AEQUALIS REVERSED,Eiberg Retractor, Standard,Eiberg Retractor, Standard, Long,Eikon LT Adapt, 135 mm,Eikon LT Adapt, 135 mm… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | GAD |
| Device names | GAD - Retractor |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HOWMEDICA OSTEONICS CORP, MAKO SURGICAL CORP., STRYKER ENDOSCOPY, STRYKER GmbH, STRYKER IRELAND OSTEONICS, TORNIER Inc., TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2249697, 2936485, 8031020, 9616680, 3000931034, 3004983210, 3010667733, 3017410889 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002459190, 3002807830, 3003070421, 3004983210, 3005985723, 3010667733 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- None listed 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