Nuvasive, Inc.

Address:4670 E. SHELBY DR.,MEMPHIS,TN,38118,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) (5) Sterilization wrap containers, trays, cassettes & other accessories (KCT) (5)

Premarket Exempt

No Yes

Clear

Cohere - 00195377000286 Catalog Number :

Device Description : COHERE Pivoting Trial, 12x14x34mm 8°

Device Class : 1

Duns Number: 053950783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cohere - 00195377000293 Catalog Number :

Device Description : COHERE Pivoting Trial, 12x14x30mm 8°

Device Class : 1

Duns Number: 053950783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cohere - 00195377000309 Catalog Number :

Device Description : COHERE Pivoting Trial, 12x11x34mm 15°

Device Class : 1

Duns Number: 053950783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cohere - 00195377000316 Catalog Number :

Device Description : COHERE Pivoting Trial, 11x9x30mm 15°

Device Class : 1

Duns Number: 053950783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cohere - 00195377000323 Catalog Number :

Device Description : COHERE Pivoting Trial, 11x14x30mm 8°

Device Class : 1

Duns Number: 053950783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

TLX - 00195377000644 Catalog Number :

Device Description : Launch TLX 20° Low-profile Instruments

Device Class : 2

Duns Number: 053950783

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

Coalesce - 00195377000866 Catalog Number :

Device Description : Coalesce Straight 28mm PLIF Implant Set

Device Class : 2

Duns Number: 053950783

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

ReLine - 00195377003096 Catalog Number :

Device Description : Alpha RELINE-O VBD 2 Instrument Set

Device Class : 2

Duns Number: 053950783

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

ReLine - 00195377003102 Catalog Number :

Device Description : Alpha RELINE-O VBD 2 Connector Set

Device Class : 2

Duns Number: 053950783

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

Modulus - 00195377003119 Catalog Number :

Device Description : Alpha Modulus ALIF Trial Tray 1

Device Class : 2

Duns Number: 053950783

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

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