FDA.reportPublic FDA data

OMNI Hip

Primary DI
00841690119562
Brand
OMNI Hip
Company
Omnilife Science, Inc
Model
H3-82854
Catalog number
H3-82854
Device description
Bipolar Head, 54mm OD, 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
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841690119562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690119562008416901195628416901195620841690119562

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head bipolar componentA sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

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 GmbHKWY2026-03-26
04048844693411implaFit®implantcast GmbHKWY2026-03-26
04048844693442implaFit®implantcast GmbHKWY2026-03-26
04048844693510implaFit®implantcast GmbHKWY2026-03-26
04048844693565implaFit®implantcast GmbHKWY2026-03-26
04048844693596implaFit®implantcast GmbHKWY2026-03-26
04048844732103n/aimplantcast GmbHKWY2026-03-24
04048844731984implaFit®implantcast GmbHKWY2026-03-20
04048844731991implaFit®implantcast GmbHKWY2026-03-20
04048844732028implaFit®implantcast GmbHKWY2026-03-20
10885862639622AcuMatchExactech, Inc.KWY2026-03-19
10885862661227N/AExactech, Inc.KWY2026-03-19
10885862661241N/AExactech, Inc.KWY2026-03-19
10885862661265N/AExactech, Inc.KWY2026-03-19
10885862663160AcuMatchExactech, Inc.KWY2026-03-19
00887868551635StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
04048844693350implaFit®implantcast GmbHKWY2026-03-17
04048844693374implaFit®implantcast GmbHKWY2026-03-17
04048844693381implaFit®implantcast GmbHKWY2026-03-17
04048844693398implaFit®implantcast GmbHKWY2026-03-17
04048844693404implaFit®implantcast GmbHKWY2026-03-17
04048844693428implaFit®implantcast GmbHKWY2026-03-17
04048844693435implaFit®implantcast GmbHKWY2026-03-17
04048844693459implaFit®implantcast GmbHKWY2026-03-17
04048844693466implaFit®implantcast GmbHKWY2026-03-17
04048844693473implaFit®implantcast GmbHKWY2026-03-17
04048844693497implaFit®implantcast GmbHKWY2026-03-17
04048844693503implaFit®implantcast GmbHKWY2026-03-17
04048844693527implaFit®implantcast GmbHKWY2026-03-17