FDA.report

b-ONE™ 12/14 Taper Femoral Head

Primary DI
00843575102201
Brand
b-ONE™ 12/14 Taper Femoral Head
Company
B-ONE ORTHO, CORP.
Model
8811036800
Catalog number
8811036800
Device description
Femoral Head, CoCr; 36mm Diameter, +8mm Neck Length
Published
2019-03-08
Public version status
New
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

Product Codes

CodeName
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications

CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843575102201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575102201008435751022018435751022010843575102201

GMDN Terms

TermDefinition
Metallic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal (e.g., titanium alloy). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip arthroplasty. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081315444
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
false

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