FDA.reportPublic FDA data

14 (w) X 15 (d) Saber-C Cervical Plate

Primary DI
00810017911752
Brand
14 (w) X 15 (d) Saber-C Cervical Plate
Company
ELEVATION SPINE, INC.
Model
CP-4506
Catalog number
CP-4506
Device description
Saber-C Plate, 14x15x6 0 deg.
Published
2019-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190885000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190885000Elevation Spine Saber-C SystemElevation Spine2019-08-07OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017911752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017911752008100179117528100179117520810017911752

GMDN Terms#

Term, Definition table
TermDefinition
Intervertebral-body internal spinal fixation systemA group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-415-0226info@elevationspine.com

Regulatory Flags#

DUNS number
085718404
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810017916450Saber-C522-0020-12522-0020-122026-07-07
00810017916467Saber-C522-0020-14522-0020-142026-07-07
00810017916474Saber-C522-0020-16522-0020-162026-07-07
00810017916481Saber-C522-0020-18522-0020-182026-07-07
00810017916498Saber-C522-0020-20522-0020-202026-07-07
00810017913893Saber-C Body (PT), 14x17x6 6 deg.CBT-4766-PCBT-4766-P2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.CBT-4767-PCBT-4767-P2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.CBT-4768-PCBT-4768-P2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.CBT-4769-PCBT-4769-P2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.CP-2525CP-25252026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.CP-2526CP-25262026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.CP-2527CP-25272026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.CP-2528CP-25282026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.CP-2529CP-25292026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.CP-2521CP-25212026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.CP-4729CP-47282026-06-25
00810017913664Saber-C Body (PT), 12x15x7 6 deg.CBT-2567-PCBT-2567-P2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.CP-4726CP-47262026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.CP-4727CP-47272026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.CP-4728CP-47282026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776391560CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391577CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391584CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391591CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391607CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391614CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391621CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391638CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391645CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391652CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391669CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391676CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391553CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-08
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.ODP2026-06-25