FDA.reportPublic FDA data

Ascension®

Primary DI
10381780236115
Brand
Ascension®
Company
Ascension Orthopedics, Inc.
Model
TRL10140D
Catalog number
TRL-101-40D
Device description
Ascension® MCP Distal Metal Trial Size 40
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022892000ASCENSION SILLICONE MCPAscension Orthopedics, Inc.2002-11-25KYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780236115PrimaryGS10
M269TRL10140D1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178023611510381780236115

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

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
00885556856925Silicone 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