FDA.report

UniSyn® Hip System

Primary DI
00844588009235
Brand
UniSyn® Hip System
Company
CONSENSUS ORTHOPEDICS, INC.
Model
3425-11921-0
Catalog number
3425-11921-0
Device description
Stem, Bowed, Fluted, Cementless
Published
2015-10-16
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications

CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844588009235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588009235008445880092358445880092350844588009235

GMDN Terms

TermDefinition
Press-fit hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined, and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

Device Sizes

TypeValueUnit
Outer Diameter19Millimeter

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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00844588006258Consensus® Knee System2153-0-00032153-0-00032015-10-05
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