NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Address:101 Enterprise Ste 100,Aliso Viejo,CA,92656,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

Rod, Fixation, Intramedullary And Accessories (HSB) (7) Orthopedic Manual Surgical Instrument (LXH) (2) Instrument, Compression (HWN) (1)

Premarket Exempt

No Yes

Clear

Precice® Fast Distractor Max - 00195377039910 Catalog Number :

Device Description : Sterile Precice Fast Distractor Max

Device Class : 1

Duns Number: 837845234

Premarket Exempt : Yes

Product Code : HWN

Prescription Use : Yes

Device Count : 1

Precice® - 00195377039927 Catalog Number :

Device Description : 3.2mm x 125mm Steinmann Pin, trocar tip

Device Class : 1

Duns Number: 837845234

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Precice External Remote Controller - 00195377083302 Catalog Number : ERC 4P

Device Description : PRECICE ERC 4P

Device Class : 2

Duns Number: 837845234

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Precice External Remote Controller - 00195377097309 Catalog Number : SW0011

Device Description : PRECICE Prescription Program

Device Class : 2

Duns Number: 837845234

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Precice External Remote Controller - 00195377099105 Catalog Number : ERC 2P

Device Description : Precice ERC 2P

Device Class : 2

Duns Number: 837845234

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

PRECICE System - 00195377108029 Catalog Number :

Device Description : Cannulated Extractor

Device Class : 1

Duns Number: 837845234

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

PRECICE® Intramedullary Limb Lengthening System - 00812258020002 Catalog Number : CPA1-000

Device Description : End Cap for PRECICE Intramedullary Limb Lengthening System Implant

Device Class : 2

Duns Number: 837845234

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

PRECICE® Intramedullary Limb Lengthening System - 00812258020019 Catalog Number : P8.5-50A215

Device Description : Orthopedic intramedullary limb lengthening rod, retrograde femur, 10°, 8.5 mm di Orthopedic intramedullary limb lengthening rod, retrograde femur, 10°, 8.5 mm diameter, 215 mm length

Device Class : 2

Duns Number: 837845234

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

PRECICE® Intramedullary Limb Lengthening System - 00812258020026 Catalog Number : P8.5-50A230

Device Class : 2

Duns Number: 837845234

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

PRECICE® Intramedullary Limb Lengthening System - 00812258020033 Catalog Number : P8.5-80A245

Device Class : 2

Duns Number: 837845234

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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