FDA.reportPublic FDA data

Plate Impactor Inserter

Primary DI
00810017914883
Brand
Plate Impactor Inserter
Company
ELEVATION SPINE, INC.
Model
522-85000
Catalog number
522-85000
Device description
Plate Impactor Inserter
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
00810017914883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017914883008100179148838100179148830810017914883

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable 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
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
0081001791176914 (w) X 15 (d) Saber-C Cervical PlateCP-4507CP-45072019-12-20
0081001791177614 (w) X 15 (d) Saber-C Cervical PlateCP-4508CP-45082019-12-20
0081001791178314 (w) X 15 (d) Saber-C Cervical PlateCP-4509CP-45092019-12-20
0081001791179014 (w) X 15 (d) Saber-C Cervical PlateCP-4501CP-45012019-12-27
0081001791180614 (w) X 15 (d) Saber-C Cervical PlateCP-4565CP-45652019-12-27
0081001791181314 (w) X 15 (d) Saber-C Cervical PlateCP-4566CP-45662019-12-27
0081001791182014 (w) X 15 (d) Saber-C Cervical PlateCP-4567CP-45672019-12-27
0081001791183714 (w) X 15 (d) Saber-C Cervical PlateCP-4568CP-45682019-12-27
0081001791184414 (w) X 15 (d) Saber-C Cervical PlateCP-4569CP-45692019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857596894OZARK Cervical Plate SystemVB Spine LLCKWQ2026-05-28
00840354204958Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204965Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204972Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204989Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204996Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205009Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205016Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205023Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205030Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205047Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205054Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205061Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205078Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205085Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205092Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205108Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205115Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205122Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205139Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205146Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205153Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205160Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205177Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205184Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205191Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205207Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06