FDA.reportPublic FDA data

OrthoCircle Spine Pedicle Screw System

Primary DI
00810005110167
Brand
OrthoCircle Spine Pedicle Screw System
Company
OrthoCircle Spine
Model
101.117
Device description
Pistol Persuader
Published
2020-04-10
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
00810005110167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005110167008100051101678100051101670810005110167

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. 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
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28