FDA.reportPublic FDA data

Straight, Spring-Loaded Drill

Primary DI
00810017914135
Brand
Straight, Spring-Loaded Drill
Company
ELEVATION SPINE, INC.
Model
CI-STR-DRILL
Catalog number
CI-STR-DRILL
Device description
Straight, Spring-Loaded Drill
Published
2024-01-16
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
00810017914135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017914135008100179141358100179141350810017914135

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
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)XAB-M1312XAB-M13122026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HXAP-M13XAP-M132026-10-01
00810017915668SABER-XA, Trial InserterXA-INS-TRIALXA-INS-TRIAL2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedXA-AWL-SXA-AWL-S2026-09-29
00810017916108SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)XAB-S1106XAB-S11062026-09-29
00810017916115SABER-XA, Expandable Spacer, 34x26mm, 13mm, (12°)XAB-S1312XAB-S13122026-09-29
00810017916122SABER-XA, Expandable Spacer, 34x26mm, 16mm, (18°)XAB-S1618XAB-S16182026-09-29
00810017916177SABER-XA, Expandable Spacer, 37x28mm,11mm, (6°)XAB-M1106XAB-M11062026-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.KWQ2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.OVE2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.KWQ2026-10-01
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19