Innovasis, Inc.

Address:614 E 3900 S,SALT LAKE CITY,UT,84107,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

Appliance, Fixation, Spinal Interlaminal (KWP) (10) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

No Yes

Clear

Excella®-M - M71100065450 Catalog Number : 0006545

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100065500 Catalog Number : 0006550

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100065550 Catalog Number : 0006555

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100065600 Catalog Number : 0006560

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100075300 Catalog Number : 0007530

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100075350 Catalog Number : 0007535

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100075400 Catalog Number : 0007540

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100075450 Catalog Number : 0007545

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100075500 Catalog Number : 0007550

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100075550 Catalog Number : 0007555

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

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