FDA.report

UniSyn Hip System

Primary DI
00840286836364
Brand
UniSyn Hip System
Company
Shalby Advanced Technologies, Inc.
Model
3427-11716-0
Catalog number
3427-11716-0
Device description
Stem, PLUS, Straight, Cementless, 17×160mm, +1mm
Published
2022-01-22
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

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
00840286836364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286836364008402868363648402868363640840286836364

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.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
085976260
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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00840286860031Consensus Knee System2800-0-20242800-0-20242025-07-07
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00840286853132Consensus Knee System2800-0-20142800-0-20142025-06-04
00840286841016Bipolar Hip System55050-0055050-002025-05-22
00840286841023Bipolar Hip System1914-2-00001914-2-00002025-05-22
00840286841030Bipolar Hip System1814-0-42441814-0-42442025-05-22
00840286841047Bipolar Hip System1814-0-45471814-0-45472025-05-22
00840286841054Bipolar Hip System1814-0-48501814-0-48502025-05-22
00840286841061Bipolar Hip System1814-0-51531814-0-51532025-05-22
00840286841078Bipolar Hip System1814-0-54561814-0-54562025-05-22
00840286841085Bipolar Hip System1814-0-57591814-0-57592025-05-22
00840286841092Bipolar Hip System1814-0-60621814-0-60622025-05-22
00840286841108Bipolar Hip System1914-0-00421914-0-00422025-05-22
00840286841115Bipolar Hip System1914-0-00431914-0-00432025-05-22
00840286841122Bipolar Hip System1914-0-00441914-0-00442025-05-22
00840286841139Bipolar Hip System1914-0-00451914-0-00452025-05-22
00840286841146Bipolar Hip System1914-0-00461914-0-00462025-05-22

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