FDA.reportPublic FDA data

APEX Knee System

Primary DI
00841690186908
Brand
APEX Knee System
Company
Omni Life Science, Inc.
Model
XK-00249
Catalog number
XK-00249
Device description
KNEE SLAP HAMMER
Published
2023-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841690186908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690186908008416901869088416901869080841690186908

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
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
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
00842078100219HammerFiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100479IO FiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100486XMCPEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
04250337122432iLESSYS® Interlaminar Endoscopic Surgical SystemJoimax GmbHLXH2026-10-29
07630699700689Knee InstrumentsMedacta International SALXH2026-10-29
08800017276182LOSPACorentec Co., LtdLXH2026-10-29
08806373878039LOSPACorentec Co., LtdLXH2026-10-29
08806373889653LOSPACorentec Co., LtdLXH2026-10-29
08806373894190LOSPACorentec Co., LtdLXH2026-10-29
10850070500101Core Wire, Removal Tool, ReusableCURVAFIX, INC.LXH2026-10-29
10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28