FDA.reportPublic FDA data

CarboClear Posterior Cervical Screw System

Primary DI
07290117351062
Brand
CarboClear Posterior Cervical Screw System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Bone Tap
Catalog number
CS016
Device description
Bone Tap for use with the CarboClear Posterior Cervical Screw System
Published
2025-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior Cervical Screw System
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233989000CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.2024-03-27NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117351062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117351062072901173510627290117351062

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97299511511info@carbo-fix.com
1-800-408-0120usa@carbo-fix.com

Regulatory Flags#

DUNS number
649185170
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117353738CarboClear Hybrid Pedicle Screw SystemMIS Rod FeelerHYB0102026-07-27
07290117352113CarboClear Hybrid Pedicle Screw SystemMIS Rod FeelerHYBM112024-07-15
07290117359549CarboClear Posterior Cervical Screw SystemShaped Rod - Type ACRC40012026-07-13
07290117359563CarboClear Posterior Cervical Screw SystemShaped Rod - Type BCRC40022026-07-13
07290117351024CarboClear Posterior Cervical Screw SystemDrill BitCS0122024-06-05
07290110209780CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5020N2021-06-29
07290110209797CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5025N2021-06-28
07290110209803CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5030N2021-06-28
07290110209810CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5035N2021-06-28
07290110209827CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5040N2021-06-28
07290110209834CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5045N2021-06-28
07290123860107CarboClear Posterior Cervical Screw SystemHybrid Angle AdjusterHCS062026-03-30
07290123860114CarboClear Posterior Cervical Screw SystemHybrid Counter TorqueHCS072026-03-30
07290117356869CarboClear Posterior Cervical Screw SystemSet ScrewHCS40002026-03-25
07290117356906CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40182026-03-25
07290117356913CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40202026-03-25
07290117356920CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40222026-03-25
07290117356937CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40242026-03-25
07290117356944CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40262026-03-25
07290117356951CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40282026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311258635C-Plus PEEK IBF SystemXtant Medical Holdings, Inc.ODP2026-08-26
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00193982521134QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521219QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521226QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521233QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521240QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521257QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521264QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521271QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00810017913695Saber-C Body (PT), 12x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-08-14
00889095368611QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368628QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368635QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368642QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03