OrthoCircle Spine

Address:15 E Montgomery Xrd Ste 3,Savannah,GA,31406,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

Clear

OrthoCircle Spine Pedicle Screw System - 00810005110310 Catalog Number :

Device Description : Tab Breaker

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110334 Catalog Number :

Device Description : Bone Awl

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110341 Catalog Number :

Device Description : 30mm Rod Trial

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110358 Catalog Number :

Device Description : 40mm Rod Trial

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110372 Catalog Number :

Device Description : Locking Driver Sleeve

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicel Screw System - 00810005110389 Catalog Number :

Device Description : 4.5 x 20mm Polyaxial-Non-Reduction Screw Set incl. Set Screw

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110396 Catalog Number :

Device Description : 4.5 x 25mm Polyaxial-Non-Reduction Screw Set incl. Set Screw

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110402 Catalog Number :

Device Description : 4.5 x 30mm Polyaxial-Non-Reduction Screw Set incl. Set Screw

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110419 Catalog Number :

Device Description : 4.5 x 35mm Polyaxial-Non-Reduction Screw Set incl. Set Screw

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

OrthoCircle Spine Pedicle Screw System - 00810005110426 Catalog Number :

Device Description : 4.5 x 45mm Polyaxial-Non-Reduction Screw Set incl. Set Screw

Device Class : 2

Duns Number: 040985864

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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