FDA.reportPublic FDA data

CarboClear Posterior Cervical Screw System

Primary DI
07290117350973
Brand
CarboClear Posterior Cervical Screw System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Adjustable Drill Guide
Catalog number
CS007
Device description
Part of the CarboClear Posterior Cervical Screw System Instrumentation Set, serves as a guide and sleeve during the drilling and tapping procedure.
Published
2024-06-05
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
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
07290117350973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117350973072901173509737290117350973

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

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
00763000992521INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00763000992552INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
04546540371508OASYSStryker CorporationNKG2015-09-14
04546540371553OASYSStryker CorporationNKG2015-09-14
04546540371560OASYSStryker CorporationNKG2015-09-14
04546540371577OASYSStryker CorporationNKG2015-09-14
04546540371584OASYSStryker CorporationNKG2015-09-14
04546540371591OASYSStryker CorporationNKG2015-09-14
04546540371607OASYSStryker CorporationNKG2015-09-14
04546540371614OASYSStryker CorporationNKG2015-09-14
04546540371621OASYSStryker CorporationNKG2015-09-14
04546540371638OASYSStryker CorporationNKG2015-09-14
04546540371645OASYSStryker CorporationNKG2015-09-14
04546540371652OASYSStryker CorporationNKG2015-09-14
04546540371669OASYSStryker CorporationNKG2015-09-14
04546540371676OASYSStryker CorporationNKG2015-09-14
04546540371683OASYSStryker CorporationNKG2015-09-14
04546540371690OASYSStryker CorporationNKG2015-09-14
04546540371706OASYSStryker CorporationNKG2015-09-14