FDA.reportPublic FDA data

FOCUS Interbody System

Primary DI
00810005113328
Brand
FOCUS Interbody System
Company
OrthoCircle Spine
Model
203.1813
Device description
27L x 10W x 13H x 18 LA
Published
2022-11-15
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005113328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005113328008100051133288100051133280810005113328

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040985864
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005110266OrthoCircle Spine Pedicle Screw System101.1272020-04-13
00810005110273OrthoCircle Spine Pedicle Screw System101.1282020-04-13
00810005110150OrthoCircle Spine Pedicle Screw System101.1162020-04-10
00810005111249OrthoCircle Spine Pedicle Screw SystemSSC1.0112020-03-29
00810005110778OrthoCircle Spine Pedicle Screw SystemPR45055.S112020-07-21
00810005110792OrthoCircle Spine Pedicle Screw SystemPR45050.S112020-07-21
00810005110808OrthoCircle Spine Pedicle Screw SystemPR45045.S112020-07-21
00810005110815OrthoCircle Spine Pedicle Screw SystemPR45060.S112020-07-21
00810005110822OrthoCircle Spine Pedicle Screw SystemPR55020.S112020-07-21
00810005110730OrthoCircle Spine Pedicel Screw SystemPR45020.S112020-07-09
00810005110747OrthoCircle Spine Pedicle Screw SystemPR45025.S112020-07-09
00810005110754OrthoCircle Spine Pedicle Screw SystemPR45030.S112020-07-09
00810005110761OrthoCircle Spine Pedicle Screw SystemPR45035.S112020-07-09
00810005110785OrthoCircle Spine Pedicle Screw SystemPR45040.S112020-07-09
00810005110471OrthoCircle Spine Pedicel Screw SystemPNR55020.S112020-05-14
00810005110488OrthoCircle Spine Pedicle Screw SystemPNR55025.S112020-05-14
00810005110532OrthoCircle Spine Pedicle Screw SystemPNR55050.S112020-05-14
00810005110549OrthoCircle Spine Pedicle Screw SystemPNR55055.S112020-05-14
00810005110556OrthoCircle Spine Pedicle Screw SystemPNR55060.S112020-05-14
00810005110570OrthoCircle Spine Pedicle Screw SystemPNR65020.S112020-05-14

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