FDA.reportPublic FDA data

Ascension MCP Joint Replacement

Primary DI
00885556856734
Brand
Ascension MCP Joint Replacement
Company
Smith & Nephew, Inc.
Model
MCP-100-20D-WW
Catalog number
MCP-100-20D-WW
Device description
MCP SZ. 20 DISTAL WW
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
NEGFinger semi-constrained pyrolytic carbon uncemented prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented ProsthesisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000057007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000057007ASCENSION MCPSmith & Nephew, Inc.2001-11-19NEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556856734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556856734008855568567348855568567340885556856734

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556856710Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856758Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856772Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856796Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856819Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856727Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856741Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856765Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856789Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856802Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856826Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
10381780000341Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000358Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000365Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000372Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000389Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000396Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000402Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000419Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000426Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000433Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000440Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000457Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP11005DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP11005PWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10010DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10010PWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10020DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10020PWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10030DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18