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Orthosis, Cranial

FDA product code MVA · 39 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5970
Review panel: NE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2000-07-07 – 2024-08-30

MVA 2024-08-30

Talee, Talee PostOp

Applicant Invent Medical USA, LLC

K number K241957

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MVA 2023-06-22

Talee, Talee PostOp

Applicant Invent Medical USA, LLC

K number K230444

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MVA 2023-04-20

STARband 3D

Applicant Orthomerica Products, Inc.

K number K223238

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MVA 2022-09-22

Talee, Talee PostOP

Applicant Invent Medical USA, LLC

K number K220681

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MVA 2022-07-01

Hanger Cranial Band 3D

Applicant Symbion Logistics, LLC

K number K203134

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MVA 2022-06-09

MyCRO Band

Applicant Otto Bock Healthcare LP

K number K213587

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MVA 2021-06-07

SnugKap

Applicant Headstart, Ltd.

K number K193383

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MVA 2021-03-26

MyCRO Band

Applicant Otto Bock Healthcare LP

K number K201426

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MVA 2018-10-16

KidCap

Applicant Eastern Cranial Affiliates, LLC

K number K180568

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MVA 2011-08-22

BOSTON BAND

Applicant Boston Brace Intl., Inc.

K number K111609

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MVA 2011-08-15

CRANIAL REMOLDING ORTHOSIS

Applicant Orthotic Care Services, Llp

K number K111247

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MVA 2011-04-18

AOI CRANIAL HELMET

Applicant Advanced Orthopro, Inc.

K number K103362

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MVA 2010-01-06

MICHIGAN CRANIAL RESHAPING ORTHOSIS

Applicant Danmar Products, Inc.

K number K090341

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MVA 2007-09-10

CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)

Applicant Mike Miner

K number K070694

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MVA 2007-07-02

CRANIAL SOLUTION ORTHOSIS

Applicant Cranial Solutions

K number K063133

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MVA 2006-12-22

O&P BIVALVE CRANIAL MOLDING HELMET

Applicant Orthotic & Prosthetic Lab, Inc.

K number K063395

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MVA 2004-12-17

DOC BAND-POSTOP

Applicant Cranial Technologies, Inc.

K number K042385

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MVA 2004-09-09

CRANIAL HELMET

Applicant Otto Bock Healthcare LP

K number K041215

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MVA 2003-11-13

COPC BAND

Applicant Center For Orthotic and Prosthetic Care,Llc

K number K021594

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MVA 2003-10-31

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

Applicant Danmar Products, Inc.

K number K013452

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MVA 2003-07-18

PROVIDENCE MOLDING HELMET

Applicant Northeast Orthotics and Prothetics, Inc.

K number K030669

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MVA 2003-01-13

LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET

Applicant Rehabilitation Institute,Loma Linda University Med

K number K023572

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MVA 2002-09-09

CRANIAL SYMMETRY SYSTEM

Applicant Beverly Hills Prosthetics Orthotics, Inc.

K number K022273

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MVA 2002-07-01

O&P CRANICAL MOLDING HELMET

Applicant Orthotic & Prosthetic Lab, Inc.

K number K021221

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MVA 2002-04-12

STATIC CRANIOPLASTY ORTHOSIS

Applicant Eastern Cranial Affiliates

K number K020448

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MVA 2002-02-05

BECKER BAND CRANIAL REMOLDING ORTHOSIS

Applicant Becker Orthopedic Appliance Co.

K number K013719

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MVA 2002-02-05

ORTHOSIS HELMET MOLDING

Applicant Precision Prosthetics & Orthotics, Inc.

K number K013700

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MVA 2002-01-17

PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS

Applicant Scott E Allen CP

K number K012804

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MVA 2001-11-28

MOLDED CRANIAL HELMET

Applicant Fairview Orthopedic Laboratory

K number K012920

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MVA 2001-11-20

LERMAN & SON CRANIAL ORTHOSIS HELMET

Applicant Lerman & Son

K number K012830

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MVA 2001-10-29

CRANIAL HELMET

Applicant Children'S Hospital

K number K013458

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MVA 2001-09-19

RHS HELMET

Applicant Restorative Health Svs, Inc.

K number K012007

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MVA 2001-06-12

BALLERT CRANIAL MOLDING HELMET

Applicant Gema, Inc.

K number K011433

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MVA 2001-06-06

CLARREN HELMET

Applicant Children'S Hospital & Medical Center

K number K003035

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MVA 2001-05-29

DANMAR PRODUCTS MICHIGAN CRANIAL HELMET

Applicant Danmar Products, Inc.

K number K003630

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MVA 2001-04-25

CRANIAL MOLDING ORTHOSIS

Applicant Orthotic Solutions, Inc.

K number K010273

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MVA 2000-12-08

HANGER CRANIAL BAND

Applicant Hanger Orthopedic Group, Inc.

K number K001669

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MVA 2000-10-30

CRANIOCAP

Applicant Gillette Children'S Specialty Healthcare

K number K000861

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MVA 2000-07-07

OPI BAND

Applicant Orthomerica Products, Inc.

K number K001167

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