FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327195705
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
1235-V-0027
Catalog number
1235-V-0027
Device description
ADM/MDM SLEEVE TRIAL (FOR 28MM HEADS ONLY)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327195705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327195705076133271957057613327195705

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982648084ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648114ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648152ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648183ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648206ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648275ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648299ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648305ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648336ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648527ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648619ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648626ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648688ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648695ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648725ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648749ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648756ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648794ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648893ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982648978ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649029ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649050ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649098ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649166ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649197ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649203ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
00193982649227ONVOYGLOBUS MEDICAL, INC.MBL2025-07-14
08033390301329DELTALIMACORPORATE SPAMBL2025-06-10
08033390301336DELTALIMACORPORATE SPAMBL2025-06-10
00822409016174Tri-plusOrtho Development CorporationMBL2023-11-22