510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K013719Substantially Equivalent

Becker Band Cranial Remolding Orthosis

Becker Orthopedic Appliance Co., Troy MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013719 is the FDA 510(k) clearance record for BECKER BAND CRANIAL REMOLDING ORTHOSIS, a class II device, cleared for Becker Orthopedic Appliance Co. on under FDA product code MVA (Orthosis, Cranial). FDA records list one 510(k) clearance for Becker Orthopedic Appliance Co. As of , FDA records show no recalls naming K013719.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MVA Orthosis, Cranial
Regulation
21 CFR 882.5970
Device class
Class II
Review panel
Neurology
Applicant
Becker Orthopedic Appliance Co. 635 Executive Dr., Troy MI
510(k) summary
Summary
Third party review
No

Clearances, product code MVA

Trailing 12 months

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

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