SWANSON

Primary DI
00840420130600
Brand
SWANSON
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
4520005J
Catalog number
4520005J
Published
2016-09-17
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
KYIPROSTHESIS, WRIST, CARPAL TRAPEZIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYIProsthesis, Wrist, Carpal TrapeziumOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864489000SWANSON TITANIUM TRAPEZIUM IMPLANTDow Corning Wright1987-04-15KYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420130600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420130600008404201306008404201306000840420130600

GMDN Terms#

Term, Definition table
TermDefinition
Total wrist carpus prosthesisA sterile implantable device designed to replace some of the carpal bone complex bearing surfaces as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is implanted into hand bone distally; it interfaces with a polyethylene (PE) spacer proximally. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
807201207
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
00889797080392PRO-DENSE LoVisc87SRLV0587SRLV052023-11-21
00889797080415PRO-DENSE LoVisc87SRLV1087SRLV102023-11-21
00889797103589PRO-DENSE LoVisc87SRLV2087SRLV202023-11-21
00889797109796PRO-DENSE LoVisc1420LVGA1420LVGA2023-11-21
00889797076005MINI IGNITE 2.0876P0020876P00202022-08-23
00889797076012MINI IGNITE 2.0876P0040876P00402022-08-23
00889797076036IGNITE 2.0876P0200876P02002022-08-23
00889797076029IGNITE™ 2.0876P0080876P00802022-02-24
00889797072700PRO-DENSE™87SR015087SR01502020-09-08
00889797072717PRO-DENSE™87SR040087SR04002020-09-08
00889797072724PRO-DENSE™87SRCDK087SRCDK02020-09-08
00889797072748PRO-DENSE™87SR002087SR00202020-09-08
00889797072755PRO-DENSE™87SR005087SR00502020-09-08
00889797072762PRO-DENSE™87SR010087SR01002020-09-08
00889797073301PRO-DENSE™87SR007087SR00702020-09-08
00889797073318PRO-DENSE™87SR012087SR01202020-09-08
00840420133434OSTEOSET84000211840002112015-10-15
00840420133465OSTEOSET84000305840003052015-10-15
00840420133472OSTEOSET84000310840003102015-10-15
00840420133489OSTEOSET84000311840003112015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M209178000THUMB MOD HEAD TITANIIUM 12MMBIOPRO, INC.KYI2024-06-30
M209178010THUMB MOD HEAD TITANIUM 12MM+2BIOPRO, INC.KYI2024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MMBIOPRO, INC.KYI2024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2BIOPRO, INC.KYI2024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MMBIOPRO, INC.KYI2024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2BIOPRO, INC.KYI2024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MMBIOPRO, INC.KYI2024-05-30
00810063560201Ensemble CMCEnsemble Orthopedics, Inc.KYI2023-08-01
00885556830789PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830840PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830857PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830864PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830871PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556830888PyroSphere CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857748NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857755NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857762NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857779NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857786NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857793NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857809NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857816NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857823NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857915NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857922NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857939NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857946NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22
00885556857953NuGrip CMCSmith & Nephew, Inc.KYI2022-12-22