510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964102Substantially Equivalent

Tenet Tibial Fracture Support

Tenet Medical Engineering, Calgary Alberta, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964102 is the FDA 510(k) clearance record for TENET TIBIAL FRACTURE SUPPORT, a class I device, cleared for Tenet Medical Engineering on under FDA product code GBB (Chair, Surgical, Ac-Powered). FDA records list 3 510(k) clearances for Tenet Medical Engineering, from to . As of , FDA records show no recalls naming K964102.

Clearance record

Decision date
Received
(55 days to decision)
Product code
GBB Chair, Surgical, Ac-Powered
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Tenet Medical Engineering 2nd. Floor 2004 - 10 Ave. SW, Calgary Alberta, CA
510(k) summary
Statement
Third party review
No

Clearances, product code GBB

Trailing 12 months

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

FDA records show no clearances under product code GBB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GBB, 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