FDA.reportPublic FDA data

3 DEGREE

Primary DI
18257200059324
Brand
3 DEGREE
Company
Orthofix US LLC
Model
60-6220
Device description
22MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Published
2019-03-19
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
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020620000BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)Blackstone Medical, Inc.2002-05-23KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200059324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720005932418257200059324

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
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
18257200115112Collage7100052016-03-02
18257200115129Collage7100102016-03-02
18257200115136Collage7100152016-03-02
18257200121861Collage7110102016-09-14
18257200121878Collage7110152016-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169371TAURUS LX Pedicle Screw SystemCTL Medical CorporationKWQ2026-11-04
08800322699775AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699782AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699799AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704032AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704049AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704056AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719654AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719661AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719678AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719685AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719692AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799939AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799946AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799953AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809969AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809976AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809983AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809990AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
B06221006200White Pearl Preferred Angle ACPOsseus Fusion Systems, LLCKWQ2017-10-09