FDA.report

OMNI Knee

Primary DI
00841690103493
Brand
OMNI Knee
Company
Omnilife Science, Inc
Model
KC-37034
Catalog number
KC-37034
Device description
Standard Tibial Insert CR, Size 3 x 14 mm
Published
2015-11-27
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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841690103493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690103493008416901034938416901034930841690103493

GMDN Terms

TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)448-6664CS@omnils.com

Regulatory Flags

DUNS number
061339651
Device count
1
DM exempt
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841690129943APEX Knee SystemKP-22613KP-226132021-07-08
00841690100805APEX CR KneeKC-1101LKC-1101L2015-11-27
00841690100812APEX CR KneeKC-1101RKC-1101R2015-11-27
00841690100829APEX CR KneeKC-1102LKC-1102L2015-11-27
00841690100836APEX CR KneeKC-1102RKC-1102R2015-11-27
00841690100843APEX CR KneeKC-1103LKC-1103L2015-11-27
00841690100850APEX CR KneeKC-1103RKC-1103R2015-11-27
00841690100867APEX CR KneeKC-1104LKC-1104L2015-11-27
00841690100874APEX CR KneeKC-1104RKC-1104R2015-11-27
00841690100881APEX CR KneeKC-1105LKC-1105L2015-11-27
00841690100898APEX CR KneeKC-1105RKC-1105R2015-11-27
00841690100904APEX CR KneeKC-1106LKC-1106L2015-11-27
00841690100911APEX CR KneeKC-1106RKC-1106R2015-11-27
00841690100928APEX CR KneeKC-1125LKC-1125L2015-11-27
00841690100935APEX CR KneeKC-1125RKC-1125R2015-11-27
00841690100942APEX CR KneeKC-1135LKC-1135L2015-11-27
00841690100959APEX CR KneeKC-1135RKC-1135R2015-11-27
00841690100966APEX CR KneeKC-1145LKC-1145L2015-11-27
00841690100973APEX CR KneeKC-1145RKC-1145R2015-11-27
00841690101000OMNI KneeKC-2201LKC-2201L2015-11-27

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