510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964927Substantially Equivalent

Stabilizer Soft Tissue Anchor, 8Mm Model Ta1008, Anchor Inserter/suture Organizer, 8Mm Model Ai1008, Stabilizer Drill, 8

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

K964927 is the FDA 510(k) clearance record for STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8, a class II device, cleared for R. Thomas Grotz, M.D., Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 4 510(k) clearances for R. Thomas Grotz, M.D., Inc., from to . As of , FDA records show no recalls naming K964927.

Clearance record

Decision date
Received
(60 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
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 MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260