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Stabilizer Soft Tissue Anchor Model Number TA1005, TA1008, Anchor Inserter/Suture Organizer Model Numbers AI1005, AI1008

by R. Thomas Grotz, M.D., Inc. 510(k)

Active United States

510(k) K965111

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK965111 Date18 Feb 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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