FDA.reportPublic FDA data

NA

Primary DI
03596010385376
Brand
NA
Company
Smith & Nephew, Inc.
Model
71333204
Catalog number
71333204
Device description
ALUMINA CERAMIC 32MM FEMORAL HEAD 12/14 TAPER +4
Published
2015-08-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981847000BIOLOX ALUMINA CERAMIC FEMORAL HEADSmith & Nephew, Inc.1998-07-17LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010385376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010385376035960103853763596010385376

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). 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 with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556918937NA72205810722058102026-08-19
00885556918968NA72205911722059112026-08-19
00885556919897NA72205802722058022026-08-19
00885556919965NA72205777722057772026-08-19
00885556919972NA72205778722057782026-08-19
00885556919989NA72205790722057902026-08-19
00885556919996NA72205791722057912026-08-19
00885556920008NA72205792722057922026-08-19
00885556920015NA72205793722057932026-08-19
00885556920022NA72205800722058002026-08-19
00885556920039NA72205801722058012026-08-19
00885556920046NA72205782722057822026-08-19
00885556920053NA72205803722058032026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUD72205781722057812026-08-14
00885556924440TESSA72205783722057832026-08-14
00885556924457TESSA72205784722057842026-08-14
00885556924464NA72205785722057852026-08-14
00885556926680TESSA72205786722057862026-08-14
00885556926703TESSA72205787722057872026-08-14
00885556922170NA74034437740344372026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032064LineageMicroport Orthopedics Inc.LZO2026-08-18
00192629032033LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032040LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032057LineageMicroport Orthopedics Inc.LZO2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14