510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063395Substantially Equivalent

O&p Bivalve Cranial Molding Helmet

Orthotic & Prosthetic Lab, Inc., Webster Groves MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063395 is the FDA 510(k) clearance record for O&P BIVALVE CRANIAL MOLDING HELMET, a class II device, cleared for Orthotic & Prosthetic Lab, Inc. on under FDA product code MVA (Orthosis, Cranial). FDA records list 2 510(k) clearances for Orthotic & Prosthetic Lab, Inc., from to . As of , FDA records show no recalls naming K063395.

Clearance record

Decision date
Received
(43 days to decision)
Product code
MVA Orthosis, Cranial
Regulation
21 CFR 882.5970
Device class
Class II
Review panel
Neurology
Applicant
Orthotic & Prosthetic Lab, Inc. 748 Marshall Ave., Webster Groves MO
510(k) summary
Summary PDF
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