FDA.reportPublic FDA data

CarboClear Posterior Cervical Screw System

Primary DI
07290117359549
Brand
CarboClear Posterior Cervical Screw System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Shaped Rod - Type A
Catalog number
CRC4001
Device description
Posterior cervical rod
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254045000CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.2026-03-16NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290117359546PackageGS12In Commercial Distribution
07290117359549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011735954617290117359546
07290117359549072901173595497290117359549

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Contacts#

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

Regulatory Flags#

DUNS number
649185170
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
07290117356968CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40302026-03-25

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
07613327132359OASYSStryker CorporationNKG2015-12-04
07613327132366OASYSStryker CorporationNKG2015-12-04
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
04546540371713OASYSStryker CorporationNKG2015-09-14
04546540371720OASYSStryker CorporationNKG2015-09-14
04546540371737OASYSStryker CorporationNKG2015-09-14
04546540371744OASYSStryker CorporationNKG2015-09-14
04546540371751OASYSStryker CorporationNKG2015-09-14
04546540371768OASYSStryker CorporationNKG2015-09-14
04546540371775OASYSStryker CorporationNKG2015-09-14
04546540371782OASYSStryker CorporationNKG2015-09-14
04546540371799OASYSStryker CorporationNKG2015-09-14