FDA.reportPublic FDA data

Spectron

Primary DI
03596010386410
Brand
Spectron
Company
Smith & Nephew, Inc.
Model
71312236
Catalog number
71312236
Device description
SPECTRON EF 12/14 TAPER LONG STRAIGHT 195MM LARGE
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211176000
K240783000
K970351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH
K240783000Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.2024-10-21JDI
K970351000GLOBAL TAPER SPECTRON HIP STEMSSmith & Nephew, Inc., Orthopaedic Div.1997-02-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010386410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010386410035960103864103596010386410

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@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
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24
00885556859759Titan Modular Shoulder SystemCSA-0920-21CSA-0920-212026-09-24
00885556859766Titan Modular Shoulder SystemCSA-0920-22CSA-0920-222026-09-24
00885556859773Titan Modular Shoulder SystemCSA-0920-23CSA-0920-232026-09-24
00885556859780Titan Modular Shoulder SystemCSA-0920-24CSA-0920-242026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442100200SignatureMaterialise NVJDI2026-09-24
E31442100300SignatureMaterialise NVJDI2026-09-24
00192629032071LineageMicroport Orthopedics Inc.JDI2026-08-18
00192629031937LineageMicroport Orthopedics Inc.JDI2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
10885862015181AuraExactech, Inc.JDI2022-10-04