FDA.report

APEX Knee System

Primary DI
00841690189404
Brand
APEX Knee System
Company
Omni Life Science, Inc.
Model
KS-90300
Catalog number
KS-90300
Device description
AK3 Femoral Distal Locating Device, Fixed Bushing
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
00841690189404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690189404008416901894048416901894040841690189404

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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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