ENDOSKELETON® TL 7200-1067

GUDID 00191375009733

Cup Curette, Angled, Small, Right

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

• Primary Device ID: 00191375009733
• NIH Device Record Key: 583d3a4d-796d-49cc-aeb1-2a28164da13b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL
• Version Model Number: 7200-1067
• Catalog Number: 7200-1067
• Company DUNS: 623316978
• Company Name: TITAN SPINE, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com

Device Dimensions

• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375009733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140055

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

[00191375009733]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-27
• Device Publish Date: 2016-12-15

On-Brand Devices [ENDOSKELETON® TL]

• 00191375027751: Quick Inserter Attachment 18mm
• 00191375027744: Quick Inserter Attachment 22mm
• 00191375010142: Retractor System
• 00191375010135: Retractor, Disposable Light Mat
• 00191375010128: Retractor, Disposable Probe
• 00191375009801: Angled Surgical Case
• 00191375009795: Threaded Inserter Angled
• 00191375009788: Angled, Standard Inserter, 22mm
• 00191375009771: Angled, Standard Inserter, 18mm
• 00191375009764: Graft Tamp, Angled
• 00191375009757: Cup Curette, Angled, Large, Right
• 00191375009740: Cup Curette, Angled, Large, Left
• 00191375009733: Cup Curette, Angled, Small, Right
• 00191375009726: Cup Curette, Angled, Small, Left
• 00191375009719: Down Angled, Ring Curette
• 00191375009702: Up Angled, Ring Curette
• 00191375009696: Down Angled, Cobb Elevator
• 00191375009689: Up Angled, Cobb Elevator
• 00191375009672: 5mm Pituitary Rongeur, Angled, Left
• 00191375009665: 5mm Pituitary Rongeur, Angled, Right
• 00191375009658: 3mm Pituitary Rongeur, Angled, Left
• 00191375009641: 3mm Pituitary Rongeur, Angled, Right
• 00191375009634: Rigid Container System
• 00191375009627: Bipolar Forceps
• 00191375009610: Distractor Wedge, 6mm
• 00191375009603: Trial, 7 Deg Lordotic, 22mm x 14mm
• 00191375009597: Trial, 7 Deg Lordotic, 22mm x 13mm
• 00191375009580: Trial, 7 Deg Lordotic, 22mm x 12mm
• 00191375009573: Trial, 7 Deg Lordotic, 22mm x 11mm
• 00191375009566: Trial, 7 Deg Lordotic, 22mm x 10mm
• 00191375009559: Trial, 7 Deg Lordotic, 22mm x 9mm
• 00191375009542: Trial, 7 Deg Lordotic, 22mm x 8mm
• 00191375009535: Trial, 7 Deg Lordotic, 18mm x 14mm
• 00191375009528: Trial, 7 Deg Lordotic, 18mm x 13mm
• 00191375009511: Trial, 7 Deg Lordotic, 18mm x 12mm
• 00191375009504: Trial, 7 Deg Lordotic, 18mm x 11mm
• 00191375009498: Trial, 7 Deg Lordotic, 18mm x 10mm
• 00191375009481: Trial, 7 Deg Lordotic, 18mm x 9mm
• 00191375009474: Trial, 7 Deg Lordotic, 18mm x 8mm
• 00191375009467: Parallel, Rasp, 22 x 13mm
• 00191375009450: Parallel, Rasp, 22 x 11mm
• 00191375009443: Parallel, Rasp, 22 x 9mm
• 00191375009436: Parallel, Rasp, 22 x 7mm
• 00191375009429: Parallel, Rasp, 18 x 13mm
• 00191375009412: Parallel, Rasp, 18 x 11mm
• 00191375009405: Parallel, Rasp, 18 x 9mm
• 00191375009399: Parallel, Rasp, 18 x 7mm
• 00191375009382: Parallel, Rasp, 18 x 5mm
• 00191375009375: Slap Hammer
• 00191375009368: French No 12, Suction Tip