FDA.reportPublic FDA data

APEX Knee System

Primary DI
00841690184249
Brand
APEX Knee System
Company
Omni Life Science, Inc.
Model
KX-04420
Catalog number
KX-04420
Device description
Z knee retractor
Published
2023-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841690184249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690184249008416901842498416901842490841690184249

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-6664CS@omnils.com

Regulatory Flags#

DUNS number
061339651
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
00841690194088OMNIBoticsNV-CRT05NV-CRT052023-03-27
00841690194804OMNIBoticsNV-CAM02NV-CAM022023-03-27
00841690194835OMNIBoticsNV-CRD07NV-CRD072023-03-27
00841690194842OMNIBoticsNV-CRD06NV-CRD062023-03-27
00841690194859OMNIBoticsNV-CRD05NV-CRD052023-03-27
00841690194866OMNIBoticsNV-CRD04NV-CRD042023-03-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091100ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00198506091117ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00810220800164Adler Instrument CompanyAdler, Inc.GAD2026-05-26
00199150071685Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071692Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071708Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071715Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071760Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071777Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071784Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071807Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonThompson Surgical Instruments, Inc.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23