ORIO

GUDID M824L7711145281

ORIO-TL Curved TLIF Symmetrical Cage 11mm Wide, 5¿ Lordosis, 11 X 14 X 28mm

SPINECRAFT, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: M824L7711145281
• NIH Device Record Key: 9219c9e0-314b-4796-a2ec-70d3689f035b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORIO
• Version Model Number: L7711-14-528
• Company DUNS: 783908713
• Company Name: SPINECRAFT, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(630)920-7300
• Email: info@spinecraft.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M824L7711145281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090887

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[M824L7711145281]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-28

On-Brand Devices [ORIO]

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