ENDOSKELETON® DPK 1900-0012

GUDID 00191375030751

Disc Prep Kit, Posterior, Lateral Angled, Bayonet, Teardrop Curette, 9mm

TITAN SPINE, LLC

Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable
Primary Device ID00191375030751
NIH Device Record Keyfcb728df-3d14-41db-b997-477ccc46d2b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOSKELETON® DPK
Version Model Number1900-0012
Catalog Number1900-0012
Company DUNS623316978
Company NameTITAN SPINE, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com
Phone+1(262)242-7801
Emailproductinfo@titanspine.com

Device Dimensions

Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch
Height9 Millimeter
Length13 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100191375030751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


[00191375030751]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-08
Device Publish Date2019-09-30

On-Brand Devices [ENDOSKELETON® DPK]

00191375010845Cone Ring Curette #3, Lateral Angled
00191375010838Anterior Ring Curette, 18in Length, #3, Angled
00191375010821Cone Ring Curette #3, Straight
00191375010814Ferris Smith Pituitary, 10in Length, 4mm, Up
00191375010807Ferris Smith Pituitary, 10in Length, 4mm, Down
00191375010791Nerve Root Retractor, 10mm, X-Large
00191375010784Lamina Spreader, Large
001913750107778in Kerrison Rongeur, 4mm
001913750107608in Kerrison Rongeur, 3mm
00191375010753Long Osteotome, 15in Length, 1/4in, Straight
00191375010746#6 Curette, Angled, 15in Length, 225mm Handle
00191375010739#4 Curette, Angled, 15in Length, 225mm Handle
00191375010722#2 Curette, Angled, 15in Length, 225mm Handle
00191375010715Ferris Smith Pituitary, 10in Length, 5mm, Straight
00191375010708Ferris Smith Pituitary, 10in Length, 3mm, Up
0019137501069210in Kerrison Rongeur, 6mm
0019137501068510in Kerrison Rongeur, 4mm
0019137501067810in Kerrison Rongeur, 2mm
00191375010661Long Cobb Elevator, 15in Length, 1in Flat
00191375010654Long Cobb Elevator, 15in Length, 5/8in Flat
00191375010647Anterior Double Action Rongeur, 8mm
00191375010630Long Curette #6, 18in Length, 9in Handle, Angled
00191375010623Long Curette #4, 18in Length, 9in Handle, Angled
00191375010616Long Curette #2, 18in Length, 9in Handle, Angled
00191375010609Ferris Smith Pituitary, 10in Length, 5mm, Straight
00191375010593Ferris Smith Pituitary, 10in Length, 4mm, Straight
00191375010586Ferris Smith Pituitary, 10in Length, 3mm, Up
0019137501057910in Kerrison Rongeur, 6mm
0019137501056210in Kerrison Rongeur, 4mm
0019137501055510in Kerrison Rongeur, 2mm
00191375010548Long Cobb Elevator, 15in Length, 1in Flat
00191375010531Long Cobb Elevator, 15in Length, 5/8in Flat
00191375010524Anterior Double Action Rongeur, 8mm
00191375010517#6 Curette, Angled, 18in Length, 225mm Handle
00191375010500#4 Curette, Angled, 18in Length, 225mm Handle
00191375010494#2 Curette, Angled, 18in Length, 225mm Handle
00191375010487Cone Ring Curette #3, Lateral Angled
00191375010470Anterior Ring Curette, 18in Length, #3, Angled
00191375010463Cone Ring Curette #3, Straight
00191375010456Ferris Smith Pituitary, 10in Length, 4mm, Up
00191375010449Ferris Smith Pituitary, 10in Length, 4mm, Straight
00191375010432Ferris Smith Pituitary, 10in Length, 4mm, Down
00191375010425Nerve Root Retractor, 10mm, X-Large
00191375010418Lamina Spreader, Large
001913750104018in Kerrison Rongeur, 4mm
001913750103958in Kerrison Rongeur, 3mm
00191375010388Long Osteotome, 15in Length, 1/4in, Straight
00191375010371Long Curette #6, 15in Length, 9in Handle
00191375010364Long Curette #4, 15in Length, 9in Handle
00191375010357Long Curette #2, 15in Length, 9in Handle

Trademark Results [ENDOSKELETON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOSKELETON
ENDOSKELETON
76550301 3174488 Live/Registered
TITAN SPINE, INC.
2003-09-22
ENDOSKELETON
ENDOSKELETON
74130100 not registered Dead/Abandoned
CAROLCO PICTURES INC.
1991-01-14
ENDOSKELETON
ENDOSKELETON
74130099 1719530 Live/Registered
STUDIOCANAL, S.A.
1991-01-14
ENDOSKELETON
ENDOSKELETON
74124953 not registered Dead/Abandoned
CAROLCO PICTURES INC.
1990-12-20
ENDOSKELETON
ENDOSKELETON
74124952 not registered Dead/Abandoned
CAROLCO PICTURES INC.
1990-12-20

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