HSA · registration DE0509845Arthrex Nano SwiveLock® Suture Anchor with Fork Eyelet
SingaporeOrthopaedicsClass CArthrex, Inc.
Official record identity
- Registration number
- DE0509845
- Model name
- Disposable Kit, Nano SwiveLock®, 2.5 x 7 mm, with 2.0 mm Cannulated Drill, 2.2 mm Cannulated Drill, .86 mm Guidewires and Drill Guide; Disposable Kit, Nano SwiveLock®, 2.5 x 7 mm, with 2.0 mm Cannulated Drill, 2.2 mm Cannulated Drill, .86 mm Guidewires and Drill Guide; Nano SwiveLock® Suture Anchor with Fork Eyelet, 2.5 x 7 mm; Nano SwiveLock® Suture Anchor with Fork Eyelet, 2.5 x 7 mm
- Model identifier
- AR-8998DS; AR-8998DS-1; AR-8998T; AR-8998T-1
- Registration date
- September 26, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Arthrex, Inc.
- Registrant / registration holder
- ARTHREX SINGAPORE, PTE. LTD.
Official description
The Arthrex Nano SwiveLock® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the hand and wrist in adult patients. • Hand/Wrist: Scapholunate ligament reconstruction and ulnar/radial collateral ligament reconstruction, digital tendon transfers, carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). Excluding skeletally mature pediatric patients.
Additional source fields
- Product owner address
- 1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States
- Registrant address
- Nucleous 21 Biopolis Rd., #03-08, Singapore 138567
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.