FDA.reportPublic FDA data

Ascension MCP Joint Replacement

Primary DI
00885556856789
Brand
Ascension MCP Joint Replacement
Company
Smith & Nephew, Inc.
Model
MCP-100-40P-WW
Catalog number
MCP-100-40P-WW
Device description
MCP SZ. 40 PROXIMAL 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
00885556856789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556856789008855568567898855568567890885556856789

GMDN Terms#

Term, Definition table
TermDefinition
Metacarpophalangeal joint prosthesis, modularA implantable artificial substitute for the metacarpophalangeal (MCP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of multiple components made of metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic (e.g., polyethylene) with stems and articulating surfaces. Dedicated tools for implantation may be included.

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
00885556856734Ascension 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
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