FDA.reportPublic FDA data

Morse Head

Primary DI
07613327016765
Brand
Morse Head
Company
Howmedica Osteonics Corp.
Model
S-2722-2210
Catalog number
S-2722-2210
Device description
Femoral Head
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933359000OSTEONICS 22MM, +10 NECK BEARING HEADSOsteonics Corp.1994-03-07LWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327016765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327016765076133270167657613327016765

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
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
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
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00193982895044TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
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00193982895235TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14