FDA.reportPublic FDA data

restor3d Disposable Instrument, Cervical Cage Inserter

Primary DI
00840097502274
Brand
restor3d Disposable Instrument, Cervical Cage Inserter
Company
Restor3d
Model
6110-INSRTRM3
Device description
Disposable Inserter, Cervical Cage
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
00840097502274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097502274008400975022748400975022740840097502274

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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