OSSIO LTD

Address:8 HaTochen St.,Caesarea Central,IL

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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 Tray (OJH) (5) Screw, Fixation, Bone (HWC) (5)

Premarket Exempt

No Yes

Clear

OSSIOfiber® Compression Screw - 07290017630236 Catalog Number : OF1024048S

Device Description : OSSIOfiber® Compression Screw, 4.0X48 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 - 07290017630243 Catalog Number : OF1024050S

Device Description : OSSIOfiber® Compression Screw, 4.0X50 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Trimmable Fixation Nail System, Cannulated - 07290017630250 Catalog Number : OF2054070S

Device Description : OSSIOfiber® Trimmable Fixation Nail System, 4.0x70mm, Cannulated. Package contai OSSIOfiber® Trimmable Fixation Nail System, 4.0x70mm, Cannulated. Package contains: 1 Implant, and 1 instrument pack.

Device Class : 1

Duns Number: 600505107

Premarket Exempt : No

Product Code : OJH

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Trimmable Fixation Nail System - 07290017630267 Catalog Number : OF2012430S

Device Description : OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm.Package contains: 2 Implant OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm.Package contains: 2 Implants, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.

Device Class : 1

Duns Number: 600505107

Premarket Exempt : No

Product Code : OJH

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Trimmable Fixation Nail System - 07290017630274 Catalog Number : OF2012450S

Device Description : OSSIOfiber® Trimmable Fixation Nail System, 2.4x50mm.Package contains: 1 Implant OSSIOfiber® Trimmable Fixation Nail System, 2.4x50mm.Package contains: 1 Implant, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.

Device Class : 1

Duns Number: 600505107

Premarket Exempt : No

Product Code : OJH

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630281 Catalog Number : OF1024028S

Device Description : OSSIOfiber® Compression Screw, 4.0X28 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Trimmable Fixation Nail System - 07290017630304 Catalog Number : OF2014050S

Device Description : OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 1 Implan OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 1 Implant, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.

Device Class : 1

Duns Number: 600505107

Premarket Exempt : No

Product Code : OJH

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Trimmable Fixation Nail System - 07290017630311 Catalog Number : OF2044050S

Device Description : OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 2 Implan OSSIOfiber® Trimmable Fixation Nail System, 4.0x50mm. Package contains: 2 Implants, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.

Device Class : 1

Duns Number: 600505107

Premarket Exempt : No

Product Code : OJH

Prescription Use : Yes

Device Count : 1

OSSIOfiber® Compression Screw - 07290017630328 Catalog Number : OF1024032S

Device Description : OSSIOfiber® Compression Screw, 4.0X32 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 - 07290017630335 Catalog Number : OF1024034S

Device Description : OSSIOfiber® Compression Screw, 4.0X34 mm. Package contains: 1 Implant.

Device Class : 2

Duns Number: 600505107

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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