FDA.reportPublic FDA data

Lumbar Plate

Primary DI
M719GLP1550
Brand
Lumbar Plate
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GLP155
Device description
Lumbar Plate Short Drill
Published
2020-01-03
Public version status
New
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
M719GLP1550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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
M719GSIX1210TiLock1GSI-X1212026-08-18
M719IST80030C0TiLock1IS-T80030-C2026-08-18
M719IST80035C0TiLock1IS-T80035-C2026-08-18
M719IST80040C0TiLock1IS-T80040-C2026-08-18
M719IST80045C0TiLock1IS-T80045-C2026-08-18
M719IST80050C0TiLock1IS-T80050-C2026-08-18
M719IST80055C0TiLock1IS-T80055-C2026-08-18
M719IST80060C0TiLock1IS-T80060-C2026-08-18
M719IST80065C0TiLock1IS-T80065-C2026-08-18
M719IST80070C0TiLock1IS-T80070-C2026-08-18
M719IST80075C0TiLock1IS-T80075-C2026-08-18
M719IST80080C0TiLock1IS-T80080-C2026-08-18
M719IST80085C0TiLock1IS-T80085-C2026-08-18
M719IST80090C0TiLock1IS-T80090-C2026-08-18
M719IST80095C0TiLock1IS-T80095-C2026-08-18
M719IST80100C0TiLock1IS-T80100-C2026-08-18
M719IST80105C0TiLock1IS-T80105-C2026-08-18
M719IST80110C0TiLock1IS-T80110-C2026-08-18
M719IST80115C0TiLock1IS-T80115-C2026-08-18
M719IST80120C0TiLock1IS-T80120-C2026-08-18

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Primary DI, Brand, Company table
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00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
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00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
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00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
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