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
K262729Substantially Equivalent

TeKBrace Solo Soft Tissue Reinforcement Device

Theramicro, Cordova TN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K262729 is the FDA 510(k) clearance record for TeKBrace Solo Soft Tissue Reinforcement Device, a class II device, cleared for Theramicro on under FDA product code QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament). FDA's definition for product code QUW reads: "a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair". As of , FDA records show no recalls naming K262729.

Clearance record

Decision date
Received
(18 days to decision)
Product code
QUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Theramicro 51 Germantown Ct., Cordova TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QUW

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