FDA.reportPublic FDA data

OMNI Interface Acetabular System

Primary DI
00841690119876
Brand
OMNI Interface Acetabular System
Company
Omnilife Science, Inc
Model
H5-44828
Catalog number
H5-44828
Device description
ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, E Insert/28mm ID
Published
2015-11-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841690119876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690119876008416901198768416901198760841690119876

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844693367implaFit®implantcast GmbHLZO2026-03-26
04048844693411implaFit®implantcast GmbHLZO2026-03-26
04048844693442implaFit®implantcast GmbHLZO2026-03-26
04048844693510implaFit®implantcast GmbHLZO2026-03-26
04048844693565implaFit®implantcast GmbHLZO2026-03-26
04048844693596implaFit®implantcast GmbHLZO2026-03-26
04048844731977implaFit®implantcast GmbHLZO2026-03-20
04048844732042implaFit®implantcast GmbHLZO2026-03-20
04048844732059implaFit®implantcast GmbHLZO2026-03-20
04048844732080implaFit®implantcast GmbHLZO2026-03-20
04048844732097implaFit®implantcast GmbHLZO2026-03-20
10885862660145N/AExactech, Inc.LZO2026-03-19
10885862660152N/AExactech, Inc.LZO2026-03-19
10885862660169N/AExactech, Inc.LZO2026-03-19
10885862660176N/AExactech, Inc.LZO2026-03-19
10885862660183N/AExactech, Inc.LZO2026-03-19
10885862660190N/AExactech, Inc.LZO2026-03-19
10885862660206N/AExactech, Inc.LZO2026-03-19
10885862660213N/AExactech, Inc.LZO2026-03-19
10885862660220N/AExactech, Inc.LZO2026-03-19
10885862660237N/AExactech, Inc.LZO2026-03-19
10885862660244N/AExactech, Inc.LZO2026-03-19
10885862660251N/AExactech, Inc.LZO2026-03-19
10885862660268N/AExactech, Inc.LZO2026-03-19
10885862660275N/AExactech, Inc.LZO2026-03-19
10885862660282N/AExactech, Inc.LZO2026-03-19
10885862660299N/AExactech, Inc.LZO2026-03-19
10885862660305N/AExactech, Inc.LZO2026-03-19
10885862660312N/AExactech, Inc.LZO2026-03-19
10885862660329N/AExactech, Inc.LZO2026-03-19