FDA.reportPublic FDA data

OrthoCircle Spine Pedicle Screw System

Primary DI
00810005110037
Brand
OrthoCircle Spine Pedicle Screw System
Company
OrthoCircle Spine
Model
101.104
Device description
Locking driver Shaft
Published
2020-04-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005110037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005110037008100051100378100051100370810005110037

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
040985864
Device count
1
Lot or batch
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
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06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28