OSSIO LTD

Address:8 HaTochen St.,Caesarea Central,IL

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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) (8) Fastener, Fixation, Biodegradable, Soft Tissue (MAI) (2)

Premarket Exempt

No Yes

Clear

OSSIOfiber® Compression Screw - 07290017630342 Catalog Number : OF1024038S

Device Description : OSSIOfiber® Compression Screw, 4.0X38 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630359 Catalog Number : OF1024042S

Device Description : OSSIOfiber® Compression Screw, 4.0X42 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630366 Catalog Number : OF1024046S

Device Description : OSSIOfiber® Compression Screw, 4.0X46 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630373 Catalog Number : OF1024052S

Device Description : OSSIOfiber® Compression Screw, 4.0X52 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630380 Catalog Number : OF1024054S

Device Description : OSSIOfiber® Compression Screw, 4.0X54 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630397 Catalog Number : OF1024056S

Device Description : OSSIOfiber® Compression Screw, 4.0X56 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630403 Catalog Number : OF1024058S

Device Description : OSSIOfiber® Compression Screw, 4.0X58 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630410 Catalog Number : OF1024060S

Device Description : OSSIOfiber® Compression Screw, 4.0X60 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Suture Anchor - 07290017630601 Catalog Number : OF1034751S

Device Description : OSSIOfiber® Suture Anchor 4.75 mm with Suture Snare. Package contains: 1 Implant OSSIOfiber® Suture Anchor 4.75 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 Suture Snare.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Suture Anchor - 07290017630618 Catalog Number : OF1034752S

Device Description : OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Sutu OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black 1.8mm Suture Tape, 1 Blue/White Round #2 Suture, 4 Stainless Steel MO-6 Needles.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

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