FDA.reportPublic FDA data

restor3d Lumbar Instrumentation

Primary DI
00840097509976
Brand
restor3d Lumbar Instrumentation
Company
Restor3d, Inc.
Model
5113-B0011
Device description
ALIF Disc Prep - Level 1
Published
2024-04-17
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234087000restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D2024-01-22MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097509976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097509976008400975099768400975099760840097509976

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097535678Veritas rTSA3500-142U12026-06-03
00840097535692Veritas rTSA3500-142C12026-06-03
00840097535715Veritas rTSA3500-142U32026-06-03
00840097535739Veritas rTSA3500-142C32026-06-03
00840097535753Veritas rTSA3500-342U12026-06-03
00840097535777Veritas rTSA3500-342C12026-06-03
00840097535791Veritas rTSA3500-342U32026-06-03
00840097535814Veritas rTSA3500-342C32026-06-03
00840097535838Veritas rTSA3500-542U12026-06-03
00840097535852Veritas rTSA3500-542C12026-06-03
00840097535876Veritas rTSA3500-542U32026-06-03
00840097535890Veritas rTSA3500-542C32026-06-03
00840097534978Veritas rTSA1501-42012026-06-02
00840097534985Veritas rTSA1501-42042026-06-02
00840097513218Veritas rTSA1500-10152026-05-14
00840097513225Veritas rTSA1500-10302026-05-14
00840097513232Veritas rTSA1500-10352026-05-14
00840097513249Veritas rTSA1500-10452026-05-14
00840097532356Veritas rTSA Instrumentation6500-20472026-05-14
00840097532394Veritas rTSA Instrumentation5500-40012026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251631420200NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420217NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420224NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420231NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420248NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420255NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420262NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420279NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420286NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420293NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420309NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420316NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420323NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420330NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420347NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420354NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420361NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420378NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420385NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420392NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420408NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420415NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420422NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420439NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420446NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420453NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420460NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420477NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420484NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420491NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06