FDA.reportPublic FDA data

FlareHawk

Primary DI
00840200408059
Brand
FlareHawk
Company
Integrity Implants Inc.
Model
FHTGCT0925TT
Catalog number
FHTGCT0925TT
Device description
Shell, Lordotic 25 mm, TiH11
Published
2023-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220453000FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.2022-03-24MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840200408059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840200408059008402004080598402004080590840200408059

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8002019300customerservice@integrityimplants.com

Regulatory Flags#

DUNS number
080300717
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810004722507NAASY-00181ASY-001812020-06-03
00810004722514NAASY-00182ASY-001822020-06-03
00810004722491NAASY-00180ASY-001802019-10-07
00810004722521NAASY-00267ASY-002672019-10-07
00810004722538NAASY-00268ASY-002682019-10-07
00810004722545NAASY-00269ASY-002692019-10-07
00810004722552NAASY-00270ASY-002702019-10-07
00810004722569NAASY-00183ASY-001832019-10-07
00810004722576NAASY-00184ASY-001842019-10-07
00810004722736NAASY-00272ASY-002722019-10-07
00810004722743NAASY-00273ASY-002732019-10-07
00840200409926FlareHawkFHTPWB52025-10-02
00840200410595LineSiderASY-001962025-10-02
00840200410656NACMP-03002CMP-030022025-07-17
00810045531014FlareHawkFHTPCS0026TTSFHTPCS0026TTS2022-12-08
00810045531021FlareHawkFHTPCT0026TTSFHTPCT0026TTS2022-12-08
00810045531038FlareHawkFHTPCS0030TTSFHTPCS0030TTS2022-12-08
00810045531045FlareHawkFHTPCT0030TTSFHTPCT0030TTS2022-12-08
00840200407984FlareHawkFHTGCS0023TTFHTGCS0023TT2023-10-16
00840200407991FlareHawkFHTGCT0023TTFHTGCT0023TT2023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251631420200NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420217NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420224NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420231NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420248NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420255NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420262NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420279NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420286NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420293NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420309NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420316NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420323NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420330NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420347NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420354NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420361NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420378NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420385NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420392NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420408NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420415NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420422NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420439NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420446NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420453NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420460NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420477NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420484NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420491NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06