FDA.reportPublic FDA data

Accord

Primary DI
03596010485755
Brand
Accord
Company
Smith & Nephew, Inc.
Model
71340004
Catalog number
71340004
Device description
ACCORD SMALL 115MM 5 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
03596010485755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010485755035960104857553596010485755

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
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982520502STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
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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
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07899258608051Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
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