FDA.reportPublic FDA data

Ascension® MCP

Primary DI
10381780000419
Brand
Ascension® MCP
Company
Ascension Orthopedics, Inc.
Model
MCP10030PWW
Catalog number
MCP-100-30P-WW
Device description
Metacarpal-Phalangeal Joint Replacement Device
Published
2014-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10381780000419PrimaryGS10
M269MCP10030PWW1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178000041910381780000419

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240204Cadence™102030222016-08-24
10381780240211Cadence™10203023102030232016-08-24
10381780240228Cadence™10203024102030242016-08-24
10381780240235Cadence™102030252016-08-24
10381780240242Cadence™102030262016-08-24
10381780240754Cadence™10204202102042022016-08-24
10381780245612Titan™IMC096004301IMC-0960-043-012017-08-30
10381780246374Integra®OSG20000OSG-200-002017-08-30
10381780246381Integra®OSG20010POSG-200-10P2017-08-30
10381780246398Integra®OSG20010PVOSG-200-10PV2017-08-30
10381780246404Integra®OSG20020POSG-200-20P2017-08-30
10381780246411Integra®OSG20020PVOSG-200-20PV2017-08-30
10381780246428Integra®OSG20030POSG-200-30P2017-08-30
10381780246435Integra®OSG20030PVOSG-200-30PV2017-09-05
10381780246442Integra®OSG20040POSG-200-40P2017-09-05
10381780246459Integra®OSG20040PVOSG-200-40PV2017-08-30
10381780246466Integra®OSG35001OSG-350-012017-08-30
10381780246473Integra®OSG44200OSG-442-002017-09-05
10381780246480First Choice® DRUJ SystemOSG60000OSG-600-002017-09-05
10381780246497First Choice® DRUJ SystemOSG60001OSG-600-012017-09-05

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
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
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