Stablyx STX-IS1

GUDID 00841506104348

SKELETAL DYNAMICS L.L.C.

Metacarpal prosthesis
Primary Device ID00841506104348
NIH Device Record Keye330b87b-a9c1-4959-91ed-bd74234091a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameStablyx
Version Model NumberSTABLYX, CMC Implant, Sz. 1
Catalog NumberSTX-IS1
Company DUNS869056148
Company NameSKELETAL DYNAMICS L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506104348 [Primary]

FDA Product Code

KYIPROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-21

On-Brand Devices [Stablyx]

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

Trademark Results [Stablyx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STABLYX
STABLYX
85200631 4376854 Live/Registered
SKELETAL DYNAMICS, INC.
2010-12-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.