FDA.reportPublic FDA data

TWINFIX

Primary DI
03596010619112
Brand
TWINFIX
Company
Smith & Nephew, Inc.
Model
72202067
Catalog number
72202067
Device description
2.8 MM TWINFIX TITANIUM SUTURE ANCHOR WITH 2 ULTRABRAID SUTURES SIZE 2-0 AND NEEDLES
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972326000PEBA ANCHOR/SUTURE COMBINATIONOrthopaedic Biosystems, Ltd.1998-02-06MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010619112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010619112035960106191123596010619112

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556833933Salto Talaris Total Ankle ProsthesisMJU952TMJU952T2022-12-22
00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

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Primary DI, Brand, Company table
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00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
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00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
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00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
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00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
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