S.B.M

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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

Screw, Fixation, Bone (HWC) (5) Filler, Bone Void, Calcium Compound (MQV) (4) Fastener, Fixation, Biodegradable, Soft Tissue (MAI) (1)

Premarket Exempt

Clear

OTIS-C PLUS - 03760154001250 Catalog Number : EVO9066055

Device Description : 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OTIS-C PLUS - 03760154001267 Catalog Number : EVO9066060

Device Description : 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OTIS-C PLUS - 03760154001274 Catalog Number : EVO9066065

Device Description : 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OTIS-C PLUS - 03760154001281 Catalog Number : EVO9066070

Device Description : 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

LIGAFIX - 03760154001311 Catalog Number : COM6010R33

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

OTIS-C PLUS - 03760154001397 Catalog Number : EVO9066075

Device Description : 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate.

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

BIOSORB - 03760154001465 Catalog Number : P822365222

Device Description : Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BIOSORB - 03760154001472 Catalog Number : P822365224

Device Description : Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BIOSORB - 03760154001489 Catalog Number : P822365226

Device Description : Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BIOSORB - 03760154001496 Catalog Number : P822365228

Device Description : Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 30% porosity

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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