FDA.reportPublic FDA data

Accord

Primary DI
03596010485823
Brand
Accord
Company
Smith & Nephew, Inc.
Model
71340013
Catalog number
71340013
Device description
ACCORD STANDARD 265MM 11 CABLE TROCHANTERIC GRIP
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
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031162000
K223762000
K233949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031162000SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEMSmith & Nephew, Inc.2003-05-01JDQ
K223762000Smith & Nephew ACCORD™ Cable SystemSmith & Nephew2023-05-30HRS
K233949000ACCORD Cable SystemSmith & Nephew, Inc.2024-03-13JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010485823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010485823035960104858233596010485823

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, cerclage wire/cable, sterileA sterile assembly of implantable devices designed for general orthopaedic repairs including procedures for long bone fractures, hips, spine, bone grafting and reinforcement of bone. It may also be used for supplementary fixation and reduction with bone plate/screw systems. It typically consists of cerclage wires or cables and crimps and/or clamps made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy). It may also include instruments for the attachment of the implants such as crimping tool, cerclage wire/cable cutting tool, a tensioning tool, and a passer.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Manufacturing date on label
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
00193982520502STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520519STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520526STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520533STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520540STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520557STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520564STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520571STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00888867525924Arthrex®ARTHREX, INC.JDQ2025-10-20
00888867525931Arthrex®ARTHREX, INC.JDQ2025-10-20
07899258607887Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258607900Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654850Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654867Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654874Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654881Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654898Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654904Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654911Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654928Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258601151Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607818Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607825Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607832Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607917Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607924Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607931Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607948Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607955Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607962Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16