FDA.reportPublic FDA data

FlareHawk

Primary DI
00850231007060
Brand
FlareHawk
Company
INTEGRITY IMPLANTS INC.
Model
II-1-0112
Catalog number
FHTA-S1-06-27-A
Device description
10mm or 12mm x 27mm, 6 degree – Shim
Published
2016-08-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850231007060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850231007060008502310070608502310070600850231007060

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
8002019300singlese@integrityimplants.com

Regulatory Flags#

DUNS number
080300717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840200410656NACMP-03002CMP-030022025-07-17
00810045530307FlareHawkFHPACS0025PTSFHPACS0025PTS2022-12-08
00810045530314FlareHawkFHPACT0025PTSFHPACT0025PTS2022-12-08
00810045530321FlareHawkFHPACT0925PTSFHPACT0925PTS2022-12-08
00810045530338FlareHawkFHTACS0029PTSFHTACS0029PTS2022-12-08
00810045530345FlareHawkFHTACT0029PTSFHTACT0029PTS2022-12-08
00810045530352FlareHawkFHTACT0929PTSFHTACT0929PTS2022-12-08
00810045530567FlareHawkFHTPCS0026PTSFHTPCS0026PTS2022-12-08
00810045530574FlareHawkFHTPCT0026PTSFHTPCT0026PTS2022-12-08
00810045530581FlareHawkFHTPCS0030PTSFHTPCS0030PTS2022-12-08
00810045530598FlareHawkFHTPCT0030PTSFHTPCT0030PTS2022-12-08
00810045530680FlareHawkFHTPS200267SFHTPS200267S2022-12-12
00810045530697FlareHawkFHTPS300267SFHTPS300267S2022-12-12
00810045530703FlareHawkFHTPS400267SFHTPS400267S2022-12-12
00810045530710FlareHawkFHTPS500267SFHTPS500267S2022-12-12
00810045530727FlareHawkFHTPS106267SFHTPS106267S2022-12-12
00810045530734FlareHawkFHTPS206267SFHTPS206267S2022-12-12
00810045530741FlareHawkFHTPS306267SFHTPS306267S2022-12-12
00810045530758FlareHawkFHTPS200307SFHTPS200307S2022-12-12
00810045530765FlareHawkFHTPS300307SFHTPS300307S2022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523178865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178872Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178889Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178896Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178902Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178919Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178926Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178933Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178940Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178957Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178964Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178971Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178988Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178995Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179008Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179015Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179022Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179039Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179046Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179053Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179060Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179077Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179084Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
08800322740446Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740453Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740460Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740477Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740484Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740491Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740507Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23