Surgical Dynamics S.D. SORB E-Z TAC
by United States Surgical, A Division of Tyco Healthc
510(k) K973281
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973281 | Date3 Nov 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- The Surgical Dynamics* S.D. Sorb* E-Z Tac*
- 510(k) Number
- FDA Product Code
- MAI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Surgical Dynamics S.D. SORB E-Z TAC is an absorbable implant designed for affixing soft tissue to bone. It is used in orthopedic procedures, specifically for rotator cuff repairs and glenoid labrum or inferior glenohumeral ligament reattachment.
The device is supplied as a single-use implant and is not MRI safe. It is regulated as a Class II device with FDA 510K clearance under product code MAI. The device is manufactured by United States Surgical, A Division of Tyco Healthcare, and is stored according to the manufacturer's instructions.
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Questions
AI-generated answers, 26 Sep 2026
What is the S.D. SORB E-Z TAC implant used for?
The S.D. SORB E-Z TAC is an absorbable implant designed for affixing soft tissue to bone. It is specifically used in orthopedic procedures for rotator cuff repairs and glenoid labrum or inferior glenohumeral ligament reattachment.
Is the S.D. SORB E-Z TAC implant single-use or reusable?
The device is supplied as a single-use implant, meaning it should be used only once and then discarded. It is not designed for reuse in multiple procedures.
What are the storage requirements for the S.D. SORB E-Z TAC implant?
The S.D. SORB E-Z TAC implant should be stored according to the manufacturer's instructions. Specific storage conditions are not detailed in the provided information, so users should refer to the product documentation for proper storage guidelines.
Is the S.D. SORB E-Z TAC implant MRI safe?
No, the S.D. SORB E-Z TAC implant is not MRI safe. This means it should not be used in patients who are scheduled to undergo MRI scans, as the device could interfere with the imaging process or potentially cause complications.