FDA.reportPublic FDA data

Spectron

Primary DI
03596010040343
Brand
Spectron
Company
Smith & Nephew, Inc.
Model
112002
Catalog number
112002
Device description
SPECTRON EF FEM SMALL STR BROACH 115MM
Published
2015-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121393000SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2012-08-07MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010040343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010040343035960100403433596010040343

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327127447INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
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07613327127485INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127577INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127584INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24