Strike Hub

Primary DI
00810017914876
Brand
Strike Hub
Company
ELEVATION SPINE, INC.
Model
522-81002
Catalog number
522-81002
Device description
Strike Hub
Published
2025-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00810017914876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017914876008100179148768100179148760810017914876

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810017915354Saber-C, Spike Driver 5-7, MedialCI-DRIVER3M-5-7CI-DRIVER3M-5-72026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralCI-DRIVER3L-5-7CI-DRIVER3L-5-72026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialCI-DRIVER3M-8-9CI-DRIVER3M-8-92026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralCI-DRIVER3L-8-9CI-DRIVER3L-8-92026-06-05
00810017913657Saber-C Body (PT), 12x15x6 6 deg.CBT-2566-PCBT-2566-P2026-06-01
0081001791165312 (w) X 15 (d) Saber-C Cervical PlateCP-2568CP-25682019-12-20
0081001791166012 (w) X 15 (d) Saber-C Cervical PlateCP-2569CP-25692019-12-20
0081001791167712 (w) X 15 (d) Saber-C Cervical PlateCP-2561CP-25612019-12-20
0081001791168412 (w) X 15 (d) Saber-C Cervical PlateCP-2595CP-25952019-12-20
0081001791169112 (w) X 15 (d) Saber-C Cervical PlateCP-2596CP-25962019-12-20
0081001791170712 (w) X 15 (d) Saber-C Cervical PlateCP-2597CP-25972019-12-20
0081001791171412 (w) X 15 (d) Saber-C Cervical PlateCP-2598CP-25982019-12-20
0081001791172112 (w) X 15 (d) Saber-C Cervical PlateCP-2599CP-25992019-12-20
0081001791173812 (w) X 15 (d) Saber-C Cervical PlateCP-2591CP-25912019-12-20
0081001791174514 (w) X 15 (d) Saber-C Cervical PlateCP-4505CP-45052019-12-20
0081001791175214 (w) X 15 (d) Saber-C Cervical PlateCP-4506CP-45062019-12-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809986492807CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
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