FDA.reportPublic FDA data

Silicone MCP

Primary DI
00885556856925
Brand
Silicone MCP
Company
Smith & Nephew, Inc.
Model
SMCP-500-50-WW
Catalog number
SMCP-500-50-WW
Device description
SILICONE MCP SZ 50
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
KYJProsthesis, finger, constrained, polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYJProsthesis, Finger, Constrained, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022892000
K233670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022892000ASCENSION SILLICONE MCPAscension Orthopedics, Inc.2002-11-25KYJ
K233670000Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.2023-12-14KYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556856925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556856925008855568569258855568569250885556856925

GMDN Terms#

Term, Definition table
TermDefinition
Metacarpophalangeal joint prosthesis, one-pieceAn implantable artificial substitute for the metacarpophalangeal (MCP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component (one-piece) made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

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
08057717554519DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554526DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554533DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554540DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554557DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554564DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554571DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554588DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554595DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
00885556856871Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856888Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856895Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856901Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856918Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856963Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856970Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856987Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856994Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857007Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857014Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857021Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857038Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857045Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857052Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857069Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857076Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857083Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857090Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857106Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857113Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22