FDA.reportPublic FDA data

Synchfix

Primary DI
00889797114882
Brand
Synchfix
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
86SYN205
Catalog number
86SYN205
Device description
Syndesmosis #5 Suture
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HTNWASHER, BOLT NUT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251643000Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)2025-10-29HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797114882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797114882008897971148828897971148820889797114882

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation suture buttonA small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone plates, screws). It can be of various shapes (e.g., H-shaped, round, oblong), made of non-bioabsorbable metallic materials [e.g., titanium (Ti)] and is typically implanted with dedicated implantation instruments; it may be supplied with associated sutures/ligatures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Kit
true
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
00889797111089PROPHECY INCOMPASS33820300338203002026-06-23
00889797111096PROPHECY INCOMPASS33820302338203022026-06-23
00889797111102PROPHECY INCOMPASS33820303338203032026-06-23
00889797111119PROPHECY INCOMPASS33820304338203042026-06-23
00889797111126PROPHECY INCOMPASS33820305338203052026-06-23
00889797114820PROPHECY INCOMPASSPROPINCPROPINC2026-06-23
00889797114837PROPHECY INCOMPASSPROPINCFPROPINCF2026-06-23
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255300064ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300071ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300088ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300095ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300101ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300118ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300125ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300132ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300149ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300156ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300163ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300170ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300187ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300194ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300200ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300217ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300224ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300231ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300248ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300255ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300262ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300705ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300712ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300729ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300736ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300743ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300750ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300767ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300774ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300781ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18