Integra®

GUDID 10381780257622

CGT Implant Size 30 The Classic Flexible Great Toe implant is a third generation prosthesis designed to supplement first metatarsophalangeal joint arthroplasty. Constructed from medical grade silicone elastomer, the Classic offers a patented axial offset hinge and other advanced design features while maintaining the surgical technique of the previous generation joint replacements

Ascension Orthopedics, Inc.

Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: 10381780257622
• NIH Device Record Key: fbd2b1cb-31c1-4c3a-a233-182c5cca9df4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: CGT-30T
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832006212 [Previous]
GS1	10381780257622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023562

FDA Product Code

• KWH: PROSTHESIS, TOE, CONSTRAINED, POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-04-21
• Device Publish Date: 2016-07-25

On-Brand Devices [Integra®]

• M269PUL0920087011: Integra®Surgical Instruments The pin puller is used to slide over objects that have been drille
• M269EXT200001: Integra®Surgical Instruments The Trial Extractor is used to remove trial implants.
• M269EXT100011: Integra®Surgical Instruments MCP, Extractor, Implant The Implant Extractor is used to remove im
• 10381780364870: Proximal Humeral Fracture Plate System Right Proximal Hole Targeting Guide-LP Plate
• 10381780364863: Proximal Humeral Fracture Plate System Left Proximal Hole Targeting Guide-GT Plate
• 10381780364856: Proximal Humeral Fracture Plate System Screw Caddy Lid
• 10381780364849: Proximal Humeral Fracture Plate System Screw Caddy Base
• 10381780364832: Proximal Humeral Fracture Plate System Tray Upper
• 10381780364825: Proximal Humeral Fracture Plate System Tray Base
• 10381780364221: Surgical Instruments - 2.0mm K-wire - Threaded
• 10381780364214: Surgical Instruments - 2.0mm K-wire - Smooth
• 10381780364061: Proximal Humeral Fracture Plate System Right Proximal Hole Targeting Guide-GT Plate
• 10381780364054: Proximal Humeral Fracture Plate System Left Proximal Hole Targeting Guide-LP Plate
• 10381780250548: Humeral Resurfacing Arthroplasty Humeral Broach Sz. 3
• 10381780250531: Humeral Resurfacing Arthroplasty Humeral Broach Sz. 2
• 10381780250524: Humeral Resurfacing Arthroplasty Humeral Broach Sz. 1
• M2695030042501: Integra® Total Foot System The forceps are used to hold plates and screws in conjunction with t
• M26922042501: Integra® Total Foot System The forceps are used to hold plates and screws in conjunction with t
• M269122250200021: Integra® External Fixation System The punch is used for the half pin drill guide in the externa
• M269SDGTFS351: Integra®Total Foot System The snap-on drill guide is used for precision and accuracy when drill
• M269SDGTFS271: Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril
• M269SDGTFS251: Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril
• M269SDGTFS181: Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when dril
• M269RIGTFS181: Integra® Total Foot System The interfrag drill guide right is used for precision and accuracy w
• M269LIGTFS181: Integra®Total Foot System The interfrag drill guide is used for precision and accuracy when dri
• M269LDGTFS251: Integra®Total Foot System The locking drill guide is used for precision and accuracy when drill
• M269LDGTFS181: Integra®Total Foot System The locking drill guide is used for precision and accuracy when drill
• M269CDGTFS181: Integra® Total Foot System The compression drill guide is used for precision and accuracy when
• M2695030035451: Integra® Total Foot System The drill guide is used for precision and accuracy when drilling.
• M269SCR09200600011: Integra®Surgical Instruments The 1/8 Hex Driver is used to tighten or loosen screws.
• M269PIN09200510011: Integra®Surgical Instruments The fixation pin helps with stabilization.
• M269G107992B1: Integra®Surgical Instruments The driver handle is provided with a small AO adaptor.
• M269G107991B1: Integra®Surgical Instruments The slotted mallet is used to hit or chisel bone.
• M269MRHRMR031: Integra® Modular Radial Head MRH Reamer Sz. 03 The Modular Radial Head Reamer compresses and/
• M269MRHRMR021: Integra® Modular Radial Head MRH Reamer Sz. 02 The Modular Radial Head Reamer compresses and/
• M269MRHRMR011: Integra® Modular Radial Head MRH Reamer Sz. 01 The Modular Radial Head Reamer compresses and/
• M269MRHPLN001: Integra® Modular Radial Head The planar is used with the modular radial head.
• M269CCR89502241: Integra® Total Foot System Cone Spherical Reamer Sz. 24mm The Cone cannulated reamer is intende
• M269CCR89502211: Integra® Total Foot System Cone Spherical Reamer Sz. 21mm The Cone cannulated reamer is intende
• M269CCR89502191: Integra® Total Foot System Cone Spherical Reamer Sz. 19mm The Cone cannulated reamer is intende
• M269CCR89502161: Integra® Total Foot System Cone Spherical Reamer Sz. 16mm The Cone cannulated reamer is intende
• M269CCR89501241: Integra® Total Foot System Cup Spherical Reamer Sz. 24mm The Cup cannulated reamer is intended
• M269CCR89501211: Integra® Total Foot System Cup Spherical Reamer Sz. 21mm The Cup cannulated reamer is intended
• M269CCR89501191: Integra® Total Foot System Cup Spherical Reamer Sz. 19mm The Cup cannulated reamer is intended
• 10381780245230: Surgical Instruments Driver Handle w/SM AO
• 10381780533733: Surgical Instruments Torque Limiter
• M269G108404B1: Integra®Surgical Instruments The T-handle is provided with a large AO adaptor.
• M269OSG442001: Silicone PIP Cut Guide
• M269OSG20040PV1: PyroCarbon PIP Total Joint PIP Prox Cut Guide, Volar Appr, Sz 40
• M269OSG20040P1: PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 40