FlareHawk FHTGS306291S

GUDID 00840200406932

Shim, 12 mm or 14 mm x 29 mm, 6 degree, FH11 Sterile

Integrity Implants Inc.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00840200406932
NIH Device Record Key18b58ccf-2973-42c4-9c4d-2ee9af265e16
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlareHawk
Version Model NumberFHTGS306291S
Catalog NumberFHTGS306291S
Company DUNS080300717
Company NameIntegrity Implants Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com
Phone8002019300
Emailcustomerservice@integrityimplants.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840200406932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [FlareHawk]

00818613020960Guide Pin, Gun Inserter
00818613020953Gun Inserter, Long
00818613020786Split Shim, 12 mm or 14 mm x 23 mm, 6 degree
00818613020779Split Shim, 11 mm or 13 mm x 23 mm, 6 degree
00818613020762Split Shim, 10 mm or 12 mm x 23 mm, 6 degree
00818613020755Split Shim, 11 mm or 14 mm x 23 mm, 0 degree
00818613020748Split Shim, 10 mm or 13 mm x 23 mm, 0 degree
00818613020731Split Shim, 9 mm or 12 mm x 23 mm, 0 degree
00818613020724Split Shim, 8 mm or 11 mm x 23 mm, 0 degree
00818613020717Shell, Tall 23mm, Split Shim
00818613020700Shell, Short 23mm, Split Shim
0081861302069412 mm or 14 mm x 27 mm, 6 degree, Split Shim
0081861302068711 mm or 13 mm x 27 mm, 6 degree, Split Shim
0081861302067010 mm or 12 mm x 27 mm, 6 degree, Split Shim
0081861302066311 mm or 14 mm x 27 mm, 0 degree, Split Shim
0081861302065610 mm or 13 mm x 27 mm, 0 degree, Split Shim
008186130206499 mm or 12 mm x 27 mm, 0 degree, Split Shim
008186130206328 mm or 11 mm x 27 mm, 0 degree, Split Shim
00818613020625Shell, Tall 27mm, Split Shim
00818613020618Shell, Short 27mm, Split Shim
00818613020090Cannula Assembly 23mm
0085023100797815mm Paddle Distractor
008502310078866mm Distractor
00850231007879Shell Assembly Tall 23mm Version B
0085023100786210mm or 12mm x 33mm Version B, 6 degree – Shim
00850231007787Expandable Guide
00850231007770Cup Curette - 4mm x 10mm Oval - Straight
00850231007756Uterine Curette - 11mm x 4mm
008502310077498mm x 20mm - Angled 15 degrees
008502310077326mm Round - Angled 15 degrees
00850231007718Cup Curette - 4mm x 10mm Oval - Angled 15 degrees
00850231007701Cup Curette - 4mm x 8mm Oval - Angled 15 degrees
00850231007695Cup Curette - 4mm x 6mm Oval - Angled 15 degrees
00850231007688Cup Curette - 4mm x 6mm Oval - Straight
00850231007671Rasp - 12mm x 30mm Rectangular Angled 15 degrees
00850231007664Osteotome - 15mm Wide
0085023100765725mm Cobb Elevator
0085023100764020mm Cobb Elevator
00850231007633Shell Assembly Tall 33mm Version B
00850231007626Shell Assembly Short 33mm Version B
0085023100761912mm or 14mm x 33mm Version B, 6 degree – Shim
0085023100760211mm or 13mm x 33mm Version B, 6 degree – Shim
0085023100759611mm or 14mm x 33mm Version B, 0 degree – Shim
0085023100758910mm or 13mm x 33mm Version B, 0 degree – Shim
008502310075729mm or 12mm x 33mm Version B, 0 degree – Shim
008502310075658mm or 11mm x 33mm Version B, 0 degree – Shim
00850231007558Shell Assembly Short 23mm Version B
0085023100754112mm or 14mm x 23mm Version B, 6 degree – Shim
0085023100753411mm or 13mm x 23mm Version B, 6 degree – Shim
0085023100752710mm or 12mm x 23mm Version B, 6 degree – Shim

Trademark Results [FlareHawk]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLAREHAWK
FLAREHAWK
86930759 5205928 Live/Registered
Integrity Implants Inc.
2016-03-07

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