OrthoCircle Spine Pedicle Screw System

GUDID 00810005110648

6.5 x 60mm Polyaxial-Non-Reduction Screw Set incl. Set Screw

OrthoCircle Spine

Bone-screw internal spinal fixation system, sterile
Primary Device ID00810005110648
NIH Device Record Key66786a29-90bf-4ac3-b1b3-10c53b3a4810
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoCircle Spine Pedicle Screw System
Version Model NumberPNR65060.S11
Company DUNS040985864
Company NameOrthoCircle Spine
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810005110648 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-22
Device Publish Date2020-05-14

On-Brand Devices [OrthoCircle Spine Pedicle Screw System]

10810005111246Set Screw
00810005111232Rod Curved 5.5mm x 30mm
00810005111225Rod Curved 5.5mm x 35mm
00810005111201Rod Curved 5.5mm x 45mm
00810005111195Rod Curved 5.5mm x 55mm
00810005111188Rod Curved 5.5mm x 50mm
00810005111171Rod Curved 5.5mm x 65mm
00810005111164Rod Curved 5.5mm x 60mm
00810005111157Rod Curved 5.5mm x 70mm
00810005111133Rod Curved 5.5mm x 80mm
00810005111119Rod Curved 5.5mm x 90mm
00810005111102Rod Curved 5.5mm x 100mm
008100051107167.5 x 50mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051107097.5 x 55mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051106937.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051106867.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051106797.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051106246.5 x 50mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051106176.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051105636.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051105255.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051105185.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051105015.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051104955.5 x 30mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051105876.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw
008100051101125.5mm Tap
00810005110105101.111
00810005110099Sounder - curved
00810005110082Sounder - Straight
00810005110075Pedicle Probe - Curved
00810005110068Pedicle Probe - Straight
00810005110051Pedicle Probe - Duck Bill
00810005110044Palm Handle
00810005110037Locking driver Shaft
00810005110020Set Screw Driver
00810005110013T-Handle - Ratcheting
00810005110006Inline Handle - Ratcheting
00810005110167Pistol Persuader
00810005110150French Bender
00810005110143Rod Fork
008100051101367.5mm Tap
008100051101296.5mm Tap
0081000511164560mm Rod Trial
00810005111638Trial Rod Caddy
0081000511161450mm Rod Trial
008100051104404.5 x 50mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
008100051104334.5 x 40mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
008100051104264.5 x 45mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
008100051104194.5 x 35mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
008100051104024.5 x 30mm Polyaxial-Non-Reduction Screw Set incl. Set Screw

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