MVA · Class II · 21 CFR 882.5970

FDA Product Code MVA: Orthosis, Cranial

Leading manufacturers include Orthomerica Products, Inc., Invent Medical USA, LLC and Otto Bock Healthcare LP.

43
Total
42
Cleared
177d
Avg days
1998
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Orthosis, Cranial Devices (Product Code MVA)

43 devices
1–24 of 43
Cleared Aug 30, 2024
Talee, Talee PostOp
K241957
Invent Medical USA, LLC
Neurology · 58d
Cleared Jun 22, 2023
Talee, Talee PostOp
K230444
Invent Medical USA, LLC
Neurology · 121d
Cleared Apr 20, 2023
STARband 3D
K223238
Orthomerica Products, Inc.
Neurology · 182d
Cleared Sep 22, 2022
Talee, Talee PostOP
K220681
Invent Medical USA, LLC
Neurology · 198d
Cleared Jul 01, 2022
Hanger Cranial Band 3D
K203134
Symbion Logistics, LLC
Neurology · 620d
Cleared Jun 09, 2022
MyCRO Band
K213587
Otto Bock Healthcare LP
Neurology · 209d
Cleared Jun 07, 2021
SnugKap
K193383
Headstart, Ltd.
Neurology · 550d
Cleared Mar 26, 2021
MyCRO Band
K201426
Otto Bock Healthcare LP
Neurology · 301d
Cleared Oct 16, 2018
KidCap
K180568
Eastern Cranial Affiliates, LLC
Neurology · 225d
Cleared Oct 06, 2014
STARBAND, STARLIGHT
K141842
Orthomerica Products, Inc.
Neurology · 90d
Cleared Jun 06, 2014
STARBAND AND STARLIGHT
K140353
Orthomerica Products, Inc.
Neurology · 114d
Cleared Apr 18, 2014
P-POD
K133397
P-Pod
Neurology · 163d
Cleared Aug 22, 2011
BOSTON BAND
K111609
Boston Brace Intl., Inc.
Neurology · 74d
Cleared Aug 15, 2011
CRANIAL REMOLDING ORTHOSIS
K111247
Orthotic Care Services, Llp
Neurology · 104d
Cleared Apr 18, 2011
AOI CRANIAL HELMET
K103362
Advanced Orthopro, Inc.
Neurology · 152d
Cleared Jan 06, 2010
MICHIGAN CRANIAL RESHAPING ORTHOSIS
K090341
Danmar Products, Inc.
Neurology · 330d
Cleared Sep 10, 2007
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
K070694
Mike Miner
Neurology · 181d
Cleared Jul 02, 2007
CRANIAL SOLUTION ORTHOSIS
K063133
Cranial Solutions
Neurology · 262d
Cleared Dec 22, 2006
O&P BIVALVE CRANIAL MOLDING HELMET
K063395
Orthotic & Prosthetic Lab, Inc.
Neurology · 43d
Cleared Dec 17, 2004
DOC BAND-POSTOP
K042385
Cranial Technologies, Inc.
Neurology · 107d
Cleared Sep 09, 2004
CRANIAL HELMET
K041215
Otto Bock Healthcare LP
Neurology · 122d
Cleared Nov 13, 2003
COPC BAND
K021594
Center For Orthotic and Prosthetic Care,Llc
Neurology · 547d
Cleared Oct 31, 2003
DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
K013452
Danmar Products, Inc.
Neurology · 743d
Cleared Jan 13, 2003
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
K023572
Rehabilitation Institute,Loma Linda University Med
Neurology · 81d

About Product Code MVA - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code MVA since 1998, with 42 receiving FDA clearance (average review time: 177 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.