FDA.reportPublic FDA data

14 (w) X 17 (d) Saber-C Cervical Plate

Primary DI
00810017912087
Brand
14 (w) X 17 (d) Saber-C Cervical Plate
Company
ELEVATION SPINE, INC.
Model
CP-4799
Catalog number
CP-4799
Device description
Saber-C Plate, 14x17x9 9 deg.
Published
2019-12-27
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
00810017912087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017912087008100179120878100179120870810017912087

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
00810017915170SABER-XA, Screw Ø5.5 x 32.5XAS-5532XAS-55302026-09-22
00810017915118Saber-C Instrument CaseCI-CADDY-TRL12CI-CADDY-TRL122026-07-27
00810017915125SABER-XA, Screw Ø5.0 x 22.5XAS-5022XAS-50222026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5XAS-5032XAS-50322026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5XAS-5522XAS-55222026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5XAS-5527XAS-55272026-09-22
00810017915132SABER-XA, Screw Ø5.0 x 27.5XAS-5027XAS-50272026-09-21
00810017915682SABER-XA, Trial, 34x26mm, 11mm, (6°)XA-TS1106XA-TS11062026-09-21
00810017915699SABER-XA, Trial, 34x26mm, 13mm, (12°)XA-TS1312XA-TS13122026-09-21
00810017915705SABER-XA, Trial, 34x26mm, 16mm, (18°)XA-TS1618XA-TS16182026-09-21
00810017915712SABER-XA, Trial, 37x28mm, 9mm, (6°)XA-TM0906XA-TM09062026-09-21
00810017915729SABER-XA, Trial, 37x28mm,11mm, (6°)XA-TM1106XA-TM11062026-09-21
00810017915736SABER-XA, Trial, 37x28mm, 13mm, (12°)XA-TM1312XA-TM13122026-09-21
00810017915743SABER-XA, Trial, 37x28mm, 16mm, (18°)XA-TM1618XA-TM16182026-09-21
00810017915767SABER-XA, Trial, 40x30mm, 11mm, (6°)XA-TL1106XA-TL11062026-09-21
00810017915774SABER-XA, Trial, 40x30mm, 13mm, (12°)XA-TL1312XA-TL13122026-09-21
00810017915781SABER-XA, Trial, 40x30mm, 16mm, (18°)XA-TL1618XA-TL16182026-09-21
00810017915828SABER-XA, Simultaneous ExpanderXA-EXP-HLXA-EXP-HL2026-09-21
00810017915835SABER-XA, Spike Driver, InterbodyXA-DRV-SPK-IXA-DRV-SPK-I2026-09-21
00810017915842SABER-XA, TampXA-TAMPXA-TAMP2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
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
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
00810056993146corraCarlsmed, Inc.KWQ2026-01-30
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