FDA.report

APEX Knee System

Primary DI
00841690183129
Brand
APEX Knee System
Company
Omni Life Science, Inc.
Model
XK-42304
Catalog number
XK-42304
Device description
Inomed Patella Cover, Size XL
Published
2023-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841690183129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690183129008416901831298416901831290841690183129

GMDN Terms

TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
061339651
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00841690194057OMNIBoticsNV-LPT03NV-LPT032023-01-10
00841690194064OMNIBoticsNV-LPT02NV-LPT022023-01-10
00841690194071OMNIBoticsNV-CRT07NV-CRT072023-01-10
00841690194095OMNIBoticsNV-CAS02NV-CAS022023-01-10
00841690194101OMNIBoticsNV-CAS01NV-CAS012023-01-10
00841690194873OMNIBoticsNV-CRD03NV-CRD032023-01-10
00841690194880OMNIBoticsNV-CRD02NV-CRD022023-01-10
00841690194897OMNIBoticsNV-CRD01NV-CRD012023-01-10
00841690195382OMNIBoticsNV-CRT01NV-CRT012023-01-10
00841690195399OMNIBoticsNV-CAM01NV-CAM012023-01-10
00841690110118APEX Knee SystemKS-61108KS-611082023-01-10
00841690110125APEX Knee SystemWS-10151WS-101512023-01-10
00841690110286APEX Knee SystemWS-20151WS-201512023-01-10
00841690110460APEX Knee SystemWS-30071WS-300712023-01-10
00841690110484APEX Knee System7103007103002023-01-10
00841690110545APEX Knee SystemWS-30060WS-300602023-01-10
00841690117940APEX Knee SystemKR-71305KR-713052023-01-10
00841690119753APEX Knee SystemKS-70023KS-700232023-01-10
00841690123750APEX Knee SystemXK-00072XK-000722023-01-10
00841690183419APEX Knee SystemXK-06562XK-065622023-01-10

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