510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870084Substantially Equivalent

Rd 140 Surgical Bender

Terray Manufacturing, Inc., Ontario K7s 1l8, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870084 is the FDA 510(k) clearance record for RD 140 SURGICAL BENDER, a class I device, cleared for Terray Manufacturing, Inc. on under FDA product code HXW (Bender). FDA records list 9 510(k) clearances for Terray Manufacturing, Inc., from to . As of , FDA records show no recalls naming K870084.

Clearance record

Decision date
Received
(20 days to decision)
Product code
HXW Bender
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Terray Manufacturing, Inc. 24 Mcgonigal St. W., Ontario K7s 1l8, CA
Third party review
No

Clearances, product code HXW

Trailing 12 months

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

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