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TPLC
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show TPLC since
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Device
orthosis, cranial
Product Code
MVA
Regulation Number
882.5970
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED ORTHOPRO INC.
SUBSTANTIALLY EQUIVALENT
1
BOSTON BRACE INTL., INC.
SUBSTANTIALLY EQUIVALENT
1
DANMAR PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
EASTERN CRANIAL AFFILIATES, LLC
SUBSTANTIALLY EQUIVALENT
1
HEADSTART, LTD.
SUBSTANTIALLY EQUIVALENT
1
INVENT MEDICAL USA, LLC
SUBSTANTIALLY EQUIVALENT
3
ORTHOMERICA PRODUCTS INC.
SUBSTANTIALLY EQUIVALENT
1
ORTHOMERICA PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
2
ORTHOTIC CARE SERVICES, LLP
SUBSTANTIALLY EQUIVALENT
1
OTTO BOCK HEALTHCARE LP
SUBSTANTIALLY EQUIVALENT
2
P-POD
SUBSTANTIALLY EQUIVALENT
1
SYMBION LOGISTICS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
1
1
2017
3
3
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2
2
Failure to Auto Stop
1
1
Device Operates Differently Than Expected
1
1
Fitting Problem
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1
1
Complaint, Ill-Defined
1
1
Hematoma
1
1
Edema
1
1
Scarring
1
1
Skin Discoloration
1
1
Post Operative Wound Infection
1
1
No Known Impact Or Consequence To Patient
1
1
Injury
1
1
Swelling
1
1
Fluid Discharge
1
1
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