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Stabilizer Soft Tissue Anchor 5mm (TA1005 +3 more) - Anchor Inserter

by R. Thomas Grotz, M.D., Inc.

510(k) K973031

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973031 Date3 Nov 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MRI
Models / Variants
Anchor Inserter
Device Class
Class I
Regulation
21 CFR Part 890.3490
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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