Evolution Spine LLC

Address:2300 N Haskell Ave,Dallas,TX,75204,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

No Yes

Clear

Whistler Modular Pedicle Screw System - 00195860000014 Catalog Number : WC-C

Device Description : Locking Cap, Cannulated

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000021 Catalog Number : WC-S

Device Description : Locking Cap, Solid

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000038 Catalog Number : WC6-C

Device Description : Locking Cap, Cannulated, 6.0 mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000045 Catalog Number : WC6-S

Device Description : Locking Cap, Solid, 6.0mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000052 Catalog Number : WRC5530-C

Device Description : CoCr Curved Rod, 5.5 Dia x 30 mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000069 Catalog Number : WRC5535-C

Device Description : CoCr Curved Rod, 5.5 Dia x 35 mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000076 Catalog Number : WRC5540-C

Device Description : CoCr Curved Rod, 5.5 Dia x 40 mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000083 Catalog Number : WRC5545-C

Device Description : CoCr Curved Rod, 5.5 Dia x 45 mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000090 Catalog Number : WRC5550-C

Device Description : CoCr Curved Rod, 5.5 Dia x 50 mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860000106 Catalog Number : WRC5555-C

Device Description : CoCr Curved Rod, 5.5 Dia x 55 mm

Device Class : 2

Duns Number: 116940934

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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