FDA.reportPublic FDA data

Saber-C, Spike Driver 8-9, Lateral

Primary DI
00810017915385
Brand
Saber-C, Spike Driver 8-9, Lateral
Company
ELEVATION SPINE, INC.
Model
CI-DRIVER3L-8-9
Catalog number
CI-DRIVER3L-8-9
Device description
Saber-C, Spike Driver 8-9, Lateral
Published
2026-06-05
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
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
00810017915385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017915385008100179153858100179153850810017915385

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, single-useA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
085718404
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
true
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
00810017913695Saber-C Body (PT), 12x15x10 6 deg.CBT-2561-PCBT-2561-P2026-08-14
00810017915804SABER-XA, Height ExpanderXA-EXP-HXA-EXP-H2026-08-14
00810017915811SABER-XA, Lordosis ExpanderXA-EXP-LXA-EXP-L2026-08-14
00810017915958Slap HammerXA-SLAPXA-SLAP2026-08-14
00810017915965Slap Hammer AdaptorXA-SLAP-AXA-SLAP-A2026-08-14
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

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