FDA Registration
Active
🇮🇱 Israel
OSSIO LTD.
Reg #: 3014554088
·
FEI: 3014554088
·
Expires 2026
Products
12
Proprietary Names
41
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- OSSIO LTD.
- Registration Number
- 3014554088
- FEI Number
- 3014554088
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8 HaTochen St.
- City
- Caesarea Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K231272
Owner / Operator
- Firm Name
- Ossio Ltd.
- Operator Number
- 10059524
- Address
- 8 HaTochen St.
- City
- Caesarea
- State
- IL-NOTA
- Postal Code
- 3079861
- Country
- IL
- Correspondent
- Taly P Lindner
US Agent
- Business Name
- OSSIO INC.
- Contact Name
- Bryan Jones
- Address
- 300 TRADECENTER DRIVE, SUITE 3690
- City
- Woburn
- State
- MA
- ZIP
- 01801
- Country
- US
- [email protected]
- Phone
- 978 2898312
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-02-17 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2023-05-14 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2024-01-08 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-01-08 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2025-05-08 |
| Staple, Absorbable | MNU | Class 2 | Orthopedic | No | 2022-11-21 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-05-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-01-31 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2022-11-21 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2020-06-11 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2022-05-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-10-05 |
Proprietary Names
OSSIO Compression Screw Instruments
OSSIO Orthopedic Cannulated Nail Instrument Pack
OSSIO Single-Use AO Handle
OSSIO Tap
OSSIO Tap Pack
OSSIOfiber Trimmable Fixation Nail, Cannulated
OSSIOfiber Compression Screw
OSSIOfiber Trimmable Fixation Nail
OSSIOfiber® Suture Anchor 2.5 mm
OSSIOfiber® Suture Anchor 3.5 mm
OSSIOfiber® Suture Anchor 2.5-3.5 mm
OSSIOfiber Compression Staple
OSSIOfiber® Compression Staple
OSSIO Punch
OSSIO Punch Pack
OSSIOfiber Hammertoe Fixation Implant
OSSIOfiber Bone Pin Product Family
OSSIOfiber® Trimmable Fixation Nail
OSSIOfiber® Hammertoe Fixation System
OSSIOfiber® Hammertoe Fixation Implant
Hammertoe Instrumentation Kit, Size Medium
OSSIO Drill Bit & Drill Guide
OSSIO Drill Bit
OSSIO Drill Bit & Drill Guide Pack
OSSIO Drill Pack
1.8mm Instrument Pack For 2.5mm Suture Anchor
Compression Screw Instruments
OSSIOfiber Suture Anchor
OSSIOfiber® Suture Anchor
OSSIO Orthopedic Staple Instrument Pack
OSSIOfiber® Trimmable Fixation Nail System
OSSIOfiber® Trimmable Fixation Nail System, Cannulated
OSSIOfiber® Suture Anchor System
OSSIOfiber® Compression Staple System
OSSIOfiber® Threaded Trimmable Fixation Nail System
OSSIOfiber® Compression Screw
OSSIO Drill Guide
OSSIOfiber Trimmable Fixation Nail, 4x100mm, Cannulated
OSSIOfiber Threaded Trimmable Fixation Nail
OSSIO® Staple Sizing Guide
OSSIOfiber® Compression Screw, 3.5mm
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device