FlareHawk FHTGCT0923TT
GUDID 00840200408004
Shell, Lordotic 23 mm, TiH11
Integrity Implants Inc.
Metal-polymer composite spinal interbody fusion cage| Primary Device ID | 00840200408004 |
| NIH Device Record Key | 541e6213-c51f-4cbf-b108-5dca458b4c38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlareHawk |
| Version Model Number | FHTGCT0923TT |
| Catalog Number | FHTGCT0923TT |
| Company DUNS | 080300717 |
| Company Name | Integrity Implants Inc. |
| 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 | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840200408004 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220453
FDA Product Code
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
[00840200408004]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-24 |
| Device Publish Date | 2023-10-16 |
On-Brand Devices [FlareHawk]
| 00818613020960 | Guide Pin, Gun Inserter |
| 00818613020953 | Gun Inserter, Long |
| 00818613020786 | Split Shim, 12 mm or 14 mm x 23 mm, 6 degree |
| 00818613020779 | Split Shim, 11 mm or 13 mm x 23 mm, 6 degree |
| 00818613020762 | Split Shim, 10 mm or 12 mm x 23 mm, 6 degree |
| 00818613020755 | Split Shim, 11 mm or 14 mm x 23 mm, 0 degree |
| 00818613020748 | Split Shim, 10 mm or 13 mm x 23 mm, 0 degree |
| 00818613020731 | Split Shim, 9 mm or 12 mm x 23 mm, 0 degree |
| 00818613020724 | Split Shim, 8 mm or 11 mm x 23 mm, 0 degree |
| 00818613020717 | Shell, Tall 23mm, Split Shim |
| 00818613020700 | Shell, Short 23mm, Split Shim |
| 00818613020694 | 12 mm or 14 mm x 27 mm, 6 degree, Split Shim |
| 00818613020687 | 11 mm or 13 mm x 27 mm, 6 degree, Split Shim |
| 00818613020670 | 10 mm or 12 mm x 27 mm, 6 degree, Split Shim |
| 00818613020663 | 11 mm or 14 mm x 27 mm, 0 degree, Split Shim |
| 00818613020656 | 10 mm or 13 mm x 27 mm, 0 degree, Split Shim |
| 00818613020649 | 9 mm or 12 mm x 27 mm, 0 degree, Split Shim |
| 00818613020632 | 8 mm or 11 mm x 27 mm, 0 degree, Split Shim |
| 00818613020625 | Shell, Tall 27mm, Split Shim |
| 00818613020618 | Shell, Short 27mm, Split Shim |
| 00818613020090 | Cannula Assembly 23mm |
| 00850231007978 | 15mm Paddle Distractor |
| 00850231007886 | 6mm Distractor |
| 00850231007879 | Shell Assembly Tall 23mm Version B |
| 00850231007862 | 10mm or 12mm x 33mm Version B, 6 degree – Shim |
| 00850231007787 | Expandable Guide |
| 00850231007770 | Cup Curette - 4mm x 10mm Oval - Straight |
| 00850231007756 | Uterine Curette - 11mm x 4mm |
| 00850231007749 | 8mm x 20mm - Angled 15 degrees |
| 00850231007732 | 6mm Round - Angled 15 degrees |
| 00850231007718 | Cup Curette - 4mm x 10mm Oval - Angled 15 degrees |
| 00850231007701 | Cup Curette - 4mm x 8mm Oval - Angled 15 degrees |
| 00850231007695 | Cup Curette - 4mm x 6mm Oval - Angled 15 degrees |
| 00850231007688 | Cup Curette - 4mm x 6mm Oval - Straight |
| 00850231007671 | Rasp - 12mm x 30mm Rectangular Angled 15 degrees |
| 00850231007664 | Osteotome - 15mm Wide |
| 00850231007657 | 25mm Cobb Elevator |
| 00850231007640 | 20mm Cobb Elevator |
| 00850231007633 | Shell Assembly Tall 33mm Version B |
| 00850231007626 | Shell Assembly Short 33mm Version B |
| 00850231007619 | 12mm or 14mm x 33mm Version B, 6 degree – Shim |
| 00850231007602 | 11mm or 13mm x 33mm Version B, 6 degree – Shim |
| 00850231007596 | 11mm or 14mm x 33mm Version B, 0 degree – Shim |
| 00850231007589 | 10mm or 13mm x 33mm Version B, 0 degree – Shim |
| 00850231007572 | 9mm or 12mm x 33mm Version B, 0 degree – Shim |
| 00850231007565 | 8mm or 11mm x 33mm Version B, 0 degree – Shim |
| 00850231007558 | Shell Assembly Short 23mm Version B |
| 00850231007541 | 12mm or 14mm x 23mm Version B, 6 degree – Shim |
| 00850231007534 | 11mm or 13mm x 23mm Version B, 6 degree – Shim |
| 00850231007527 | 10mm or 12mm x 23mm Version B, 6 degree – Shim |
Trademark Results [FlareHawk]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLAREHAWK 86930759 5205928 Live/Registered |
Integrity Implants Inc. 2016-03-07 |
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