FDA.report

Bipolar Femoral Head

Primary DI
00840341102229
Brand
Bipolar Femoral Head
Company
CONSENSUS ORTHOPEDICS, INC.
Model
86-1014-0-0050
Catalog number
86-1014-0-0050
Device description
ASSY, Bipolar Femoral Head-Locking Ring
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840341102229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840341102229008403411022298403411022290840341102229

GMDN Terms

TermDefinition
Femoral head bipolar componentA sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

Device Sizes

TypeValueUnit
Outer Diameter50Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(916)355-7100zjohnson@consensusortho.com

Regulatory Flags

DUNS number
824905723
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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