FDA.reportPublic FDA data

restor3d Disposable Instrument, Cervical Cage Trial

Primary DI
00840097501062
Brand
restor3d Disposable Instrument, Cervical Cage Trial
Company
Restor3d, Inc.
Model
6110-16130707
Device description
Disposable Trial, Cervical Cage, Medium Footprint, 7mm Thickness, 0 degrees
Published
2021-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097501062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097501062008400975010628400975010620840097501062

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080819836
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097536699Kinos Aeros Instrumentation5801-10002026-07-20
00840097536668Veritas rTSA Instrumentation5500-32022026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17