510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141264Substantially Equivalent

Tensyn Band, Tensyn Fracture Plates

Dallen Medical, Inc., San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141264 is the FDA 510(k) clearance record for TENSYN BAND, TENSYN FRACTURE PLATES, a class II device, cleared for Dallen Medical, Inc. on under FDA product code HTN (Washer, Bolt Nut). FDA records list 11 510(k) clearances for Dallen Medical, Inc., from to . As of , FDA records show no recalls naming K141264.

Clearance record

Decision date
Received
(98 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Dallen Medical, Inc. 1046 Calle Recodo, Suite G, San Clemente CA
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