FDA.reportPublic FDA data

Freedom Wrist Arthroplasty System

Primary DI
00885556856147
Brand
Freedom Wrist Arthroplasty System
Company
Smith & Nephew, Inc.
Model
348330E
Catalog number
348330E
Device description
4.5MM SCREW AND LOCKING CAP 30MM LENGTH
Published
2022-12-22
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
JWJProsthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132250000INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEMIntegra LifeSciences Corporation2014-03-24JWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556856147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556856147008855568561478855568561470885556856147

GMDN Terms#

Term, Definition table
TermDefinition
Total wrist prosthesisA sterile implantable artificial substitute for a wrist joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes radial and carpal components, usually with an intervening ball/spacer, with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

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
03596010469182GENESIS II71421012714210122015-08-30
03596010469212GENESIS II71421015714210152015-08-30
03596010469229GENESIS II71421016714210162015-08-30
03596010469236GENESIS II71421017714210172015-08-30
03596010469267GENESIS II71421112714211122015-08-30
03596010469274GENESIS II71421113714211132015-08-30
03596010469281GENESIS II71421114714211142015-08-30
03596010469298GENESIS II71421115714211152015-08-30
03596010469304GENESIS II71421116714211162015-08-30
03596010469328GENESIS II71421118714211182015-08-30
03596010531018JOURNEY74024629740246292015-08-29
03596010531025JOURNEY74024632740246322015-08-29
03596010554468JOURNEY74024623740246232015-08-29
03596010554475JOURNEY74024626740246262015-08-29
03596010554512JOURNEY74024826740248262015-08-29
03596010554529JOURNEY74024829740248292015-08-29
03596010554536JOURNEY74024832740248322015-08-29
03596010000675OXINIUM71343603713436032015-08-30
03596010469199GENESIS II71421013714210132015-08-30
03596010469205GENESIS II71421014714210142015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556854839Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556854846Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556854853Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855249Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855256Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855263Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855270Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855287Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855294Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855553Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855560Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855577Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855584Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855591Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855607Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855614Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855621Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855638Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855669Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855676Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855683Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855690Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855706Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855713Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855720Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855737Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855744Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855751Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855768Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855775Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22