FDA.report

APEX Knee System

Primary DI
00841690128038
Brand
APEX Knee System
Company
Omnilife Science, Inc
Model
KC-52004
Catalog number
KC-52004
Device description
Revision Offset Stem 19mm x 100mm x 4mm
Published
2016-05-06
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
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841690128038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690128038008416901280388416901280380841690128038

GMDN Terms

TermDefinition
Body femoral/tibial extension stem, uncoatedA sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included.

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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