FDA.reportPublic FDA data

restor3d, Disposable Instrument, Cervical Cage Trial

Primary DI
00840097502267
Brand
restor3d, Disposable Instrument, Cervical Cage Trial
Company
Restor3d
Model
6110-001-17151207
Device description
Disposable Trial, Cervical Cage 001, Large Footprint, 12mm Thickness
Published
2021-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00840097502267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097502267008400975022678400975022670840097502267

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097509914restor3d Kinos Axiom PSR 5831-90032023-09-27
00840097509921restor3d Kinos Axiom PSR 5831-90042023-09-27
00840097509938restor3d Kinos Axiom PSR 5831-90052023-09-27
00840097509945restor3d Kinos Axiom PSR 5831-90062023-09-27
00840097508900Kinos Axiom Instrumentation5801-41095801.41092023-07-19
00840097508917Kinos Axiom Instrumentation5801-41055801.41052023-07-19
00840097507507Kinos Axiom Instrumentation5801-00505801.00502023-07-18
00840097507514Kinos Axiom Instrumentation5801-00515801.00512023-07-18
00840097507521Kinos Axiom Instrumentation5801-00525801.00522023-07-18
00840097509471Kinos Axiom Instrumentation5801-00185801.00182023-07-18
00840097509488Kinos Axiom Instrumentation5801-00195801.00192023-07-18
00840097509495Kinos Axiom Instrumentation5801-00205801.00202023-07-18
00840097509501Kinos Axiom Instrumentation5801-00215801.00212023-07-18
00840097509518Kinos Axiom Instrumentation5801-00222023-07-18
00840097509525Kinos Axiom Instrumentation5801-00325801.00322023-07-18
00840097505251Kinos Axiom Instrumentation5801-00132023-06-28
00840097505275Kinos Axiom Instrumentation5801-00142023-06-28
00840097507491Kinos Axiom Instrumentation5801-00472023-05-23
00840097504377Kinos Axiom Instrumentation5801-00922023-05-19
00840097504483Kinos Axiom Instrumentation5801-00462023-05-19

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