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
43 devices
25–43 of 43
Cleared Sep 09, 2002
CRANIAL SYMMETRY SYSTEM
K022273
Beverly Hills Prosthetics Orthotics, Inc.
Neurology · 56d
Cleared Jul 01, 2002
O&P CRANICAL MOLDING HELMET
K021221
Orthotic & Prosthetic Lab, Inc.
Neurology · 75d
Cleared Apr 12, 2002
STATIC CRANIOPLASTY ORTHOSIS
K020448
Eastern Cranial Affiliates
Neurology · 60d
Cleared Feb 05, 2002
ORTHOSIS HELMET MOLDING
K013700
Precision Prosthetics & Orthotics, Inc.
Neurology · 89d
Cleared Feb 05, 2002
BECKER BAND CRANIAL REMOLDING ORTHOSIS
K013719
Becker Orthopedic Appliance Co.
Neurology · 89d
Cleared Jan 17, 2002
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
K012804
Scott E Allen CP
Neurology · 149d
Cleared Nov 28, 2001
MOLDED CRANIAL HELMET
K012920
Fairview Orthopedic Laboratory
Neurology · 90d
Cleared Nov 20, 2001
LERMAN & SON CRANIAL ORTHOSIS HELMET
K012830
Lerman & Son
Neurology · 89d
Cleared Oct 29, 2001
CRANIAL HELMET
K013458
Children'S Hospital
Neurology · 11d
Cleared Sep 19, 2001
RHS HELMET
K012007
Restorative Health Svs, Inc.
Neurology · 84d
Cleared Jun 12, 2001
BALLERT CRANIAL MOLDING HELMET
K011433
Gema, Inc.
Neurology · 33d
Cleared Jun 06, 2001
CLARREN HELMET
K003035
Children'S Hospital & Medical Center
Neurology · 251d
Cleared May 29, 2001
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
K003630
Danmar Products, Inc.
Neurology · 186d
Cleared Apr 25, 2001
CRANIAL MOLDING ORTHOSIS
K010273
Orthotic Solutions, Inc.
Neurology · 86d
Cleared Dec 08, 2000
HANGER CRANIAL BAND
K001669
Hanger Orthopedic Group, Inc.
Neurology · 191d
Cleared Oct 30, 2000
CRANIOCAP
K000861
Gillette Children'S Specialty Healthcare
Neurology · 227d
Cleared Jul 07, 2000
OPI BAND
K001167
Orthomerica Products, Inc.
Neurology · 88d
Not Cleared May 29, 1998
DYNAMIC ORTHOTIC CRANIOPLASTY BAND
DEN980001
Cranial Technologies, Inc.
Neurology · 59d