510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870767Substantially Equivalent

The (Crom) Tester

Twin City Surgical, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870767 is the FDA 510(k) clearance record for THE (CROM) TESTER, a class I device, cleared for Twin City Surgical, Inc. on under FDA product code KQW (Goniometer, Nonpowered). FDA records list 6 510(k) clearances for Twin City Surgical, Inc., from to . As of , FDA records show no recalls naming K870767.

Clearance record

Decision date
Received
(19 days to decision)
Product code
KQW Goniometer, Nonpowered
Regulation
21 CFR 888.1520
Device class
Class I
Review panel
Orthopedic
Applicant
Twin City Surgical, Inc. 2800 N.Fairview Ave., St. Paul MN
Third party review
No

Clearances, product code KQW

Trailing 12 months

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

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