510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132733Substantially Equivalent

Orthohelix Syndesmosis Fixation Devices

TORNIER Inc., Medina OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132733 is the FDA 510(k) clearance record for ORTHOHELIX SYNDESMOSIS FIXATION DEVICES, a class II device, cleared for Orthohelix Surgical Designs, Inc. on under FDA product code HTN (Washer, Bolt Nut). FDA records list 140 510(k) clearances for TORNIER Inc., from to . As of , FDA records show no recalls naming K132733.

Clearance record

Decision date
Received
(122 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Orthohelix Surgical Designs, Inc. 1065 Medina Rd., Suite 500, Medina OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTN

Trailing 12 months
3 clearances under product code HTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260