510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K143692Substantially Equivalent

GranOSTM - beta tricalcium phosphate synthetic bone granules

Tcm Associates, Ltd., Naseing Essex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143692 is the FDA 510(k) clearance record for GranOSTM - beta tricalcium phosphate synthetic bone granules, a class II device, cleared for Tcm Associates, Ltd. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list one 510(k) clearance for Tcm Associates, Ltd. As of , FDA records show no recalls naming K143692.

Clearance record

Decision date
Received
(240 days to decision)
Product code
MQV Filler, Bone Void, Calcium Compound
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Tcm Associates, Ltd. 3, Hillgrove Business Park, Naseing Essex, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQV

Trailing 12 months
5 clearances under product code MQV in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260