FDA.reportPublic FDA data

Spike Implants

Primary DI
00810017915279
Brand
Spike Implants
Company
ELEVATION SPINE, INC.
Model
CQ-14
Device description
Saber-C 14mm Spikes (No Carriage)
Published
2025-09-12
Public version status
New
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
00810017915279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017915279008100179152798100179152790810017915279

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the 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
00810017915118Saber-C Instrument CaseCI-CADDY-TRL12CI-CADDY-TRL122026-07-27
00810017914548Saber-C Body (PT), 14x17x6 12 deg.CBT-4726-PCBT-4726-P2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.CBT-4728-PCBT-4728-P2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.CBT-4727-PCBT-4727-P2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.CBT-4729-PCBT-4729-P2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.CBT-4721-PCBT-4721-P2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.CP-4721CP-47212026-07-23
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
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