FDA.reportPublic FDA data

MD-Vue™ Lateral Discectomy System

Primary DI
00840019967402
Brand
MD-Vue™ Lateral Discectomy System
Company
PRECISION SPINE, INC.
Model
60-SC-7003
Catalog number
60-SC-7003
Device description
Implant Caddy - 24mm x 15° (Empty)
Published
2023-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092193000SPINAL USA INTERBODY CAGESSpinal USA2009-09-25MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019967402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019967402008400199674028400199674020840019967402

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019934909Reform Ti39-TD-555539-TD-55552019-10-04
00840019934916Reform Ti39-TD-556039-TD-55602019-10-04
00840019934923Reform Ti39-TD-652539-TD-65252019-10-04
00840019934930Reform Ti39-TD-653039-TD-65302019-10-04
00840019934947Reform Ti39-TD-653539-TD-65352019-10-04
00840019934954Reform Ti39-TD-654039-TD-65402019-10-04
00840019934961Reform Ti39-TD-654539-TD-65452019-10-04
00840019934978Reform Ti39-TD-655039-TD-65502019-10-04
00840019934985Reform Ti39-TD-655539-TD-65552019-10-04
00840019934992Reform Ti39-TD-656039-TD-65602019-10-04
00840019935005Reform Ti39-TD-753039-TD-75302019-10-04
00840019935012Reform Ti39-TD-753539-TD-75352019-10-04
00840019935029Reform Ti39-TD-754039-TD-75402019-10-04
00840019935036Reform Ti39-TD-754539-TD-75452019-10-04
00840019935043Reform Ti39-TD-755039-TD-75502019-10-04
00840019935050Reform Ti39-TD-755539-TD-75552019-10-04
00840019935067Reform Ti39-TD-756039-TD-75602019-10-04
00840019934848Reform Ti39-TD-552539-TD-55252019-10-04
00840019934855Reform Ti39-TD-553039-TD-55302019-10-04
00840019934862Reform Ti39-TD-553539-TD-55352019-10-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
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00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
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