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

Orthopedic manual surgical instrument (LXH) (6)

Premarket Exempt

No Yes

Clear

Stowe Pedicle Screw System - 00195860018064 Catalog Number : STO-I-029

Device Description : FINAL TIGHTENING DRIVER 270mm SIZE 30

Device Class : 1

Duns Number: 116940934

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LLIF Interbody System - 00195860018088 Catalog Number : L-1212

Device Description : LLIF Shaver 12mm

Device Class : 1

Duns Number: 116940934

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LLIF Interbody System - 00195860018095 Catalog Number : L-1214

Device Description : LLIF Shaver 14mm

Device Class : 1

Duns Number: 116940934

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LLIF Interbody System - 00195860018101 Catalog Number : L-1216

Device Description : LLIF Shaver 16mm

Device Class : 1

Duns Number: 116940934

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860018224 Catalog Number : WI-074

Device Description : Driver Polyaxial Screw

Device Class : 1

Duns Number: 116940934

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Whistler Modular Pedicle Screw System - 00195860018231 Catalog Number : WI-073

Device Description : Tulip Turner Blue Handle

Device Class : 1

Duns Number: 116940934

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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