ORIO 7010-02-2

GUDID 00193082078125

Bayoneted Curette, 0 deg. Up

SPINECRAFT, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00193082078125
NIH Device Record Key1f57af26-b82c-4c24-bfdf-db6362e67670
Commercial Distribution StatusIn Commercial Distribution
Brand NameORIO
Version Model Number7010-02-2
Catalog Number7010-02-2
Company DUNS783908713
Company NameSPINECRAFT, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100193082078125 [Primary]
GS100193082078125 [Primary]
GS100193082078125 [Primary]
GS100193082078125 [Primary]
GS100193082078125 [Primary]
GS100193082078125 [Primary]
GS100193082078125 [Primary]
GS100193082078125 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193082078125]

Moist Heat or Steam Sterilization


[00193082078125]

Moist Heat or Steam Sterilization


[00193082078125]

Moist Heat or Steam Sterilization


[00193082078125]

Moist Heat or Steam Sterilization


[00193082078125]

Moist Heat or Steam Sterilization


[00193082078125]

Moist Heat or Steam Sterilization


[00193082078125]

Moist Heat or Steam Sterilization


[00193082078125]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [ORIO]

00193082078712Slap Hammer
00193082078705Curved TLIF Cage Impactor
00193082078699PLIF side impactor II
00193082078682PLIF side impactor I
00193082078675Corner Impactor
00193082078668End Impactor - Angled
00193082078651End Impactor - Straight
00193082078644Bone graft compactor, large
00193082078637Bone graft compactor, small
00193082078620Curved TLIF cage inserter - Straight
00193082078606Straight TLIF cage inserter - Slim- Pistolgrip
00193082078590Straight TLIF cage inserter - Slim-Straight
00193082078583Straight TLIF cage inserter - Pistol-grip
00193082078576Straight TLIF cage inserter - Straight
00193082078569Knob Unlocker
00193082078552PLIF cage inserter - Pistol-grip
00193082078545PLIF cage inserter - Straight
00193082078538Paddle distractor, Size 15
00193082078521Paddle distractor, Size 14
00193082078514Paddle distractor, Size 13
00193082078507Paddle distractor, Size 12
00193082078491Paddle distractor, Size 11
00193082078484Paddle distractor, Size 10
00193082078477Paddle distractor, Size 09
00193082078460Paddle distractor, Size 08
00193082078453Paddle distractor, Size 07
00193082078446TLIF Disc shaver, Size 13
00193082078439TLIF Disc shaver, Size 11
00193082078422TLIF Disc shaver, Size 09
00193082078415TLIF Disc shaver, Size 07
00193082078408PLIF Disc shaver, Size 13
00193082078385PLIF Disc shaver, Size 11
00193082078361PLIF Disc shaver, Size 09
00193082078354PLIF Disc shaver, Size 07
00193082078347T-Handle, 1/4in square connection
00193082078330ORIO-L Instrument Case 2
00193082078323Optional Cages Caddy
00193082078316Curved TLIF Cages Caddy
00193082078309Straight TLIF Cages Caddy
00193082078293PLIF 5Deg. Trapezoidal Cages Caddy
00193082078286PLIF 5Deg. and PLIF 8Deg. Cages Caddy
00193082078279Bayoneted Curette, Reversed 90Deg. Down, size 4
00193082078262Bayoneted Curette, Reversed 90Deg. Down, size 2
00193082078255Curved Rasp
00193082078248Straight Rasp
00193082078231Curved Chisel
00193082078224Osteotome - Angled Handle
00193082078217Box curette
00193082078088Implant and Trial Caddy
00193082078071Implant / Instrument Case Lid

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