Stablyx STX-IS3

GUDID 00841506104362

SKELETAL DYNAMICS L.L.C.

Metacarpal prosthesis

• Primary Device ID: 00841506104362
• NIH Device Record Key: b5094bf7-b109-4306-8ccd-585ed505ebd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stablyx
• Version Model Number: STABLYX, CMC Implant, Sz. 3
• Catalog Number: STX-IS3
• Company DUNS: 869056148
• Company Name: SKELETAL DYNAMICS L.L.C.
• 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(305)596-7585
• Email: feedback@skeletaldynamics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506104362 [Primary]

FDA Product Code

• KYI: PROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-21

On-Brand Devices [Stablyx]

• 00841506105765: STABLYX System Lid
• 00841506105758: STABLYX Instrument Tray Insert
• 00841506105741: STABLYX CMC Arthroplasty System Sterilization Tray
• 00841506105390: STABLYX CMC Arthroplasty System
• 00841506105383: STABLYX, Volar Osteophyte Rasp
• 00841506105376: STABLYX, Volar Capsule Elevator / Shoehorn
• 00841506105369: STABLYX, Metacarpal Rasp, Sz. 5
• 00841506105352: STABLYX, Metacarpal Rasp, Sz. 4
• 00841506105345: STABLYX, Metacarpal Rasp, Sz. 3
• 00841506105338: STABLYX, Metacarpal Rasp, Sz. 2
• 00841506105321: STABLYX, Metacarpal Rasp, Sz. 1
• 00841506104584: Awl, Straight 2.0mm
• 00841506104577: STABLYX, Norman Suture Passer
• 00841506104560: Osteotome, Curved
• 00841506104553: STABLYX, CMC Trial, Sz. 5
• 00841506104546: STABLYX, CMC Trial, Sz. 4
• 00841506104539: STABLYX, CMC Trial, Sz. 3
• 00841506104522: STABLYX, CMC Trial, Sz. 2
• 00841506104515: STABLYX, CMC Trial, Sz. 1
• 00841506104508: STABLYX, Trapezial Contouring Tool, Sz. 1
• 00841506104492: STABLYX, Trapezial Sizer, Sz. 5
• 00841506104485: STABLYX, Trapezial Sizer, Sz. 4
• 00841506104478: STABLYX, Trapezial Sizer, Sz. 3
• 00841506104461: STABLYX, Trapezial Sizer, Sz. 2
• 00841506104454: STABLYX, Trapezial Sizer, Sz. 1
• 00841506104447: STABLYX, Metacarpal Planar, Sz. 1
• 00841506104430: STABLYX, Metacarpal Rasp, Sz. 5
• 00841506104423: STABLYX, Metacarpal Rasp, Sz. 4
• 00841506104416: STABLYX, Metacarpal Rasp, Sz. 3
• 00841506104409: STABLYX, Metacarpal Rasp, Sz. 2
• 00841506104393: STABLYX, Metacarpal Rasp, Sz. 1
• 00841506104386: STABLYX, CMC Implant, Sz. 5
• 00841506104379: STABLYX, CMC Implant, Sz. 4
• 00841506104362: STABLYX, CMC Implant, Sz. 3
• 00841506104355: STABLYX, CMC Implant, Sz. 2
• 00841506104348: STABLYX, CMC Implant, Sz. 1
• 00841506103303: STABLYX, Volar Osteophyte Rasp
• 00841506103297: STABLYX, Volar Capsule Elevator / Shoehorn
• 00841506103280: STABLYX, CMC Trial, Sz. 5
• 00841506103273: STABLYX, CMC Trial, Sz. 4
• 00841506103266: STABLYX, CMC Trial, Sz. 3
• 00841506103259: STABLYX, CMC Trial, Sz. 2
• 00841506103242: STABLYX, CMC Trial, Sz. 1
• 00841506103235: STABLYX, Trapezial Contouring Tool, Sz. 1
• 00841506103228: STABLYX, Trapezial Sizer, Sz. 5
• 00841506103211: STABLYX, Trapezial Sizer, Sz. 4
• 00841506103204: STABLYX, Trapezial Sizer, Sz. 3
• 00841506103198: STABLYX, Trapezial Sizer, Sz. 2
• 00841506103181: STABLYX, Trapezial Sizer, Sz. 1
• 00841506103174: STABLYX CMC Arthroplasty System