FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327319750
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-H1157032I
Catalog number
I-H1157032I
Device description
SPECIALTY TRIDENT SELF RETAINING INSERT TRIAL
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151264000Restoration Anatomic ShellStryker Orthopaedics2015-08-10LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327319750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327319750076133273197507613327319750

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. 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
Lumen/Inner Diameter32Millimeter

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
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24
07613327012866V40 Head6260-5-1286260-5-1282015-09-24
07613327012873V40 Head6260-5-1326260-5-1322015-09-24
07613327012880V40 Head6260-5-2266260-5-2262015-09-24
07613327012897V40 Head6260-5-2286260-5-2282015-09-24
07613327012903V40 Head6260-5-2326260-5-2322015-09-24
07613327012941V40 Head6260-5-4266260-5-4262015-09-24
07613327012958V40 Head6260-5-4286260-5-4282015-09-24
07613327012965V40 Head6260-5-4326260-5-4322015-09-24
07613327012972V40 Head6260-5-6286260-5-6282015-09-24
07613327019704Restoration5096-46255096-46252015-09-24
07613327019711Restoration5096-46155096-46152015-09-24
07613327019728Restoration5096-46205096-46202015-09-24
07613327019735Restoration5096-50155096-50152015-09-24
07613327019742Restoration5096-50205096-50202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24