FDA.reportPublic FDA data

SKYHAWK

Primary DI
18257200094721
Brand
SKYHAWK
Company
Orthofix US LLC
Model
26-1011
Device description
CURETTE - STRAIGHT #0
Published
2019-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZSCURETTE, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200094721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720009472118257200094721

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200028177PHOENIX SFS20-01012026-07-17
18257200028207PHOENIX SFS20-01202026-07-17
18257200028917FIREBIRD SFS201130732026-07-17
18257200028924FIREBIRD SFS201130742026-07-17
18257200028931FIREBIRD SFS201130752026-07-17
18257200028948FIREBIRD SFS201130762026-07-17
18257200028955FIREBIRD SFS201130782026-07-17
18257200028979FIREBIRD SFS201130802026-07-17
18257200028986FIREBIRD SFS201130812026-07-17
18257200028993FIREBIRD SFS201130822026-07-17
18257200029006FIREBIRD SFS201130832026-07-17
18257200029013FIREBIRD SFS201130842026-07-17
18257200029020FIREBIRD SFS201130852026-07-17
18257200029280FIREBIRD SFS201147972026-07-17
18257200029846FIREBIRD SFS301100252026-07-17
18257200029853FIREBIRD SFS301100262026-07-17
18257200029860FIREBIRD SFS301100272026-07-17
18257200029877FIREBIRD SFS301100282026-07-17
18257200029884FIREBIRD SFS301100292026-07-17
18257200029945FIREBIRD SFS301100352026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431068MillenniumAvalign Technologies, Inc.FZS2026-09-21
M93071015023S10Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071015024S10Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715021C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715022C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715031C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
M93071715032C900Life InstrumentsLife Instrument CorporationFZS2026-09-21
00840314270290gSourceGSOURCE LLCFZS2026-08-07
00810143906592SURGIPROSSurgipros, LLCFZS2026-07-30
00810143906608SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909777SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909784SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909807SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934136SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934143SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934150SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934167SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934174SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934181SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934198SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934204SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934211SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934228SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934235SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934242SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934259SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934266SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934273SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934280SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934297SURGIPROSSurgipros, LLCFZS2026-07-30