510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K973031Substantially Equivalent

Stabilizer Soft Tissue Anchor 5Mm Model Ta1005, Anchor Inserter/suture Organizer 5Mm Ai1005, Stabilizer Drill 5Mm Nonste

R. Thomas Grotz, M.D., Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973031 is the FDA 510(k) clearance record for STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE, a class I device, cleared for R. Thomas Grotz, M.D., Inc. on under FDA product code MRI (Orthosis, Truncal/Orthosis, Limb). FDA records list 4 510(k) clearances for R. Thomas Grotz, M.D., Inc., from to . As of , FDA records show no recalls naming K973031.

Clearance record

Decision date
Received
(81 days to decision)
Product code
MRI Orthosis, Truncal/Orthosis, Limb
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
R. Thomas Grotz, M.D., Inc. 530 Bush St., 10th Floor, San Francisco CA
510(k) summary
Summary
Third party review
No

Clearances, product code MRI

Trailing 12 months

FDA records hold no clearances under product code MRI in the trailing twelve months.

FDA records show no clearances under product code MRI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260