HSA · registration DE0510282Smith & Nephew HEALICOIL REGENESORB Suture Anchors with MINITAPE
SingaporeOrthopaedicsClass CSmith & Nephew Inc. Endoscopy
Official record identity
- Registration number
- DE0510282
- Model name
- HEALICOIL REGENESORB 4.75MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); HEALICOIL REGENESORB 4.75MM SUTURE ANCHOR WITH THREE MINITAPE SUTURES (BLUE, COBRAID WHITE, COBRAID BLUE); HEALICOIL REGENESORB 5.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); HEALICOIL REGENESORB 5.5MM SUTURE ANCHOR WITH THREE MINITAP SUTURES (BLUE, COBRAID WHITE, & COBRAID BLUE)
- Model identifier
- 72205385; 72205386; 72205387; 72205388
- Registration date
- January 24, 2025
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Smith & Nephew Inc. Endoscopy
- Registrant / registration holder
- SMITH & NEPHEW PTE. LIMITED
Official description
HEALICOIL REGENESORB Suture Anchors with MINITAPE are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder • Rotator cuff tear repairs • Capsular shift or capsulolabral reconstructions • Biceps tenodesis
Additional source fields
- Product owner address
- 150 Minuteman Road, Andover, Massachusetts, 01810, United States
- Registrant address
- 29 MEDIA CIRCLE, #06-05, ALICE@MEDIAPOLIS, Singapore 138565
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.