Innovasis, Inc.

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 - M71100055300 Catalog Number : 0005530

Device Description : Ti 6Al 4V (ELI)

Device Class : 2

Duns Number: 156567492

Premarket Exempt : No

Product Code : MNI, MNH, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Excella®-M - M71100055350 Catalog Number : 0005535

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 - M71100055400 Catalog Number : 0005540

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 - M71100055450 Catalog Number : 0005545

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 - M71100055500 Catalog Number : 0005550

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 - M71100055550 Catalog Number : 0005555

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 - M71100055600 Catalog Number : 0005560

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 - M71100065300 Catalog Number : 0006530

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 - M71100065350 Catalog Number : 0006535

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 - M71100065400 Catalog Number : 0006540

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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