FDA.reportPublic FDA data

Integra®

Primary DI
10381780235125
Brand
Integra®
Company
Ascension Orthopedics, Inc.
Model
SILPIPINSTP
Device description
The Integra Silicone PIP is intended for replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes silicone PIP trials to evaluate size and fit of the implants. Instruments are also included.
Published
2017-10-03
Public version status
Update
Distribution status
Not 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
K082231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082231000ASCENSION SILICONE PIPAscension Orthopedics, Inc.2009-01-12KYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780235125PrimaryGS10
M268SILPIPINSTP1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178023512510381780235125

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. 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
Kit
true
Serial number
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
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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