FDA.reportPublic FDA data

Restoration

Primary DI
04546540638809
Brand
Restoration
Company
Howmedica Osteonics Corp.
Model
1235-2-581
Catalog number
1235-2-581
Device description
ADM- Cup w/HA
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540638809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540638809045465406388094546540638809

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellA sterile, implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter58Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00887868477256Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868478086Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-06-22
00887868475375Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868475962Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868475979Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476044Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476068Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
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00887868476860Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868477881Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-25
00887868476372Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476556Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476662Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868476761Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-05-08
00887868475399Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868475559Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868476990Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
00887868477447Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-23
07613327511659INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
07613327511802INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
07613327511864INSTRUMENTHowmedica Osteonics Corp.MAY2022-04-15
00887868475481Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868475511Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868475894Arcos® STS™ Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868477669Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868477744Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-04-02
00887868476235Arcos® Modular Revision SystemBiomet Orthopedics, LLCMAY2022-03-12