SPINENET, LLC

Address:1300 Minnesota Avenue,Winter Park,FL,32789,US

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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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10)

Premarket Exempt

Clear

SpineNet SSP® - B047106010 Catalog Number : 106-01

Device Description : SpineNet SSP® Bone Awl-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B047106020 Catalog Number : 106-02

Device Description : SpineNet SSP® (Single Screw Plate) System, 2.4x18mm, Drill Bit-Instrument,

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B04710603120 Catalog Number : 106-03-12

Device Description : SpineNet SSP®, 12mm, Drill Sleeve-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B04710603140 Catalog Number : 106-03-14

Device Description : SpineNet SSP®, 14mm, Drill Sleeve-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B04710603160 Catalog Number : 106-03-16

Device Description : SpineNet SSP®, 16mm, Drill Sleeve-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B04710603180 Catalog Number : 106-03-18

Device Description : SpineNet SSP®, 18mm, Drill Sleeve-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B047106040 Catalog Number : 106-04

Device Description : SpineNet SSP® , Bone Tap, 4.25x12mm-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B047106060 Catalog Number : 106-06

Device Description : SpineNet SSP® Small AO Chuck Handle- Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B047106070 Catalog Number : 106-07

Device Description : SpineNet SSP®, Fixed Drill Guide-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

SpineNet SSP® - B047106080 Catalog Number : 106-08

Device Description : SpineNet SSP®, Variable Drill Guide-Instrument

Device Class : 2

Duns Number: 792052321

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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