FDA.reportPublic FDA data

CarboClear Posterior Cervical Screw System

Primary DI
17290117354688
Brand
CarboClear Posterior Cervical Screw System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Screw
Catalog number
CS4036
Device description
Posterior cervical screw
Published
2024-12-01
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
17290117354688PackageGS12In Commercial Distribution
07290117354681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011735468817290117354688
07290117354681072901173546817290117354681

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-408-0120usa@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
07290117353608CarboClear Hybrid Pedicle Screw SystemMIS Fenestrated Screw CannulaHYBM192024-07-16
07290117352021CarboClear Hybrid Pedicle Screw SystemScrew CannulaHYB0182024-07-15
07290110204617CarboClear Pedicle Screw SystemCannulaPNNDL00132019-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
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B678522201S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522202S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522203S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522204S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522205S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522206S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
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00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
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00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
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