BLACKHAWK Cervical Spacer System

GUDID 00840996186797

BLACKHAWK TI,CON.STERILE,16WX14DX10H

Choice Spine, LP

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00840996186797
• NIH Device Record Key: 658a2f8e-6ade-437b-8c8e-6b71e07cd36e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLACKHAWK Cervical Spacer System
• Version Model Number: S-TT20-1614C10
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: true
• 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(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996186797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171489

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

[00840996186797]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-13
• Device Publish Date: 2023-02-03

On-Brand Devices [BLACKHAWK Cervical Spacer System]

• 00840996168755: BLACKHAWK,FINAL LOCKING TOOL
• 00840996168748: BLACKHAWK,ANCHOR REMOVAL TOOL
• 00840996164924: BLACKHAWK,INSERTER STANDARD
• 00840996164917: BLACKHAWK,INSERTER SHORT
• 00840996164900: BLACKHAWK,LONG INSERTER, IMPACTOR
• 00840996164894: BLACKHAWK,SHORT INSERTER,IMPACTOR
• 00840996164887: BLACKHAWK,DOUBLE,IMPACTOR,STND,REWORK
• 00840996164870: BLACKHAWK,DOUBLE,IMPACTOR,SHORT,REWORK
• 00840996164757: BLACKHAWK,STERILE,CONVEX,16X14X9
• 00840996164740: BLACKHAWK,STERILE,CONVEX,16X14X8
• 00840996164733: BLACKHAWK,STERILE,CONVEX,16X14X7
• 00840996164726: BLACKHAWK,STERILE,CONVEX,16X14X6
• 00840996164719: BLACKHAWK,STERILE,CONVEX,16X14X5
• 00840996164702: BLACKHAWK,STERILE,CONVEX,14X12X10
• 00840996164696: BLACKHAWK,STERILE,CONVEX,14X12X9
• 00840996164689: BLACKHAWK,STERILE,CONVEX,14X12X8
• 00840996164672: BLACKHAWK,STERILE,CONVEX,14X12X7
• 00840996164665: BLACKHAWK,STERILE,CONVEX,14X12X6
• 00840996164658: BLACKHAWK,STERILE,CONVEX,14X12X5
• 00840996164641: BLACKHAWK,STERILE,PARALLEL,16X14X10
• 00840996164634: BLACKHAWK,STERILE,PARALLEL,16X14X9
• 00840996164627: BLACKHAWK,STERILE,PARALLEL,16X14X8
• 00840996164610: BLACKHAWK,STERILE,PARALLEL,16X14X7
• 00840996164603: BLACKHAWK,STERILE,PARALLEL,16X14X6
• 00840996164597: BLACKHAWK,STERILE,PARALLEL,16X14X5
• 00840996164580: BLACKHAWK,STERILE,PARALLEL,14X12X10
• 00840996164573: BLACKHAWK,STERILE,PARALLEL,14X12X9
• 00840996164566: BLACKHAWK,STERILE,PARALLEL,14X12X8
• 00840996164542: BLACKHAWK,STERILE,PARALLEL,14X12X6
• 00840996164535: BLACKHAWK,STERILE,PARALLEL,14X12X5
• 00840996164528: BLACKHAWK,STERILE,LORDOTIC,16X14X10
• 00840996164511: BLACKHAWK,STERILE,LORDOTIC,16X14X9
• 00840996164504: BLACKHAWK,STERILE,LORDOTIC,16X14X8
• 00840996164498: BLACKHAWK,STERILE,LORDOTIC,16X14X7
• 00840996164481: BLACKHAWK,STERILE,LORDOTIC,16X14X6
• 00840996164474: BLACKHAWK,STERILE,LORDOTIC,16X14X5
• 00840996164467: BLACKHAWK,STERILE,LORDOTIC,14X12X10
• 00840996164450: BLACKHAWK,STERILE,LORDOTIC,14X12X9
• 00840996164443: BLACKHAWK,STERILE,LORDOTIC,14X12X8
• 00840996164436: BLACKHAWK,STERILE,LORDOTIC,14X12X7
• 00840996164429: BLACKHAWK,STERILE,LORDOTIC,14X12X6
• 00840996164412: BLACKHAWK,STERILE,LORDOTIC,14X12X5
• 00840996186797: BLACKHAWK TI,CON.STERILE,16WX14DX10H
• 00840996186780: BLACKHAWK TI,CON.STERILE,16WX14DX9H
• 00840996186773: BLACKHAWK TI,CON.STERILE,16WX14DX8H
• 00840996186766: BLACKHAWK TI,CON.STERILE,16WX14DX7H
• 00840996186759: BLACKHAWK TI,CON.STERILE,16WX14DX6H
• 00840996186742: BLACKHAWK TI,CON.STERILE,16WX14DX5H
• 00840996186735: BLACKHAWK TI,PAR,STERILE,16WX14DX10H
• 00840996186728: BLACKHAWK TI,PAR,STERILE,16WX14DX9H