FDA.reportPublic FDA data

Lumbar Plate System

Primary DI
M719GLP100000210
Brand
Lumbar Plate System
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GLP-10000-021
Device description
21mm Lumbar Plate
Published
2023-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173885000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173885000Genesys Spine Binary Lumbar Plate SystemGenesys Spine2018-04-03KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GLP100000210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length21Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5123817070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M719GCL05L0Apache1GCL-05-L2015-08-31
M719GCL06L0Apache1GCL-06-L2015-08-31
M719GCL06S0Apache1GCL-06-S2015-08-31
M719GCL07L0Apache1GCL-07-L2015-08-31
M719GCL07S0Apache1GCL-07-S2015-08-31
M719GCL08L0Apache1GCL-08-L2015-08-31
M719GCL08S0Apache1GCL-08-S2015-08-31
M719GCL09L0Apache1GCL-09-L2015-08-31
M719GCL09S0Apache1GCL-09-S2015-08-31
M719GCL10L0Apache1GCL-10-L2015-08-31
M719GCL10S0Apache1GCL-10-S2015-08-31
M719GCL11L0Apache1GCL-11-L2015-08-31
M719GCL11S0Apache1GCL-11-S2015-08-31
M719GCL12L0Apache1GCL-12-L2015-08-31
M719GCL12S0Apache1GCL-12-S2015-08-31
M719GCX05L0Apache1GCX-05-L2015-08-31
M719GCX05S0Apache1GCX-05-S2015-08-31
M719GCX06L0Apache1GCX-06-L2015-08-31
M719GCX06S0Apache1GCX-06-S2015-08-31
M719GCX07L0Apache1GCX-07-L2015-08-31

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Primary DI, Brand, Company table
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00810017916498Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
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00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
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