FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
K Number: K201803
·
Decision Oct 16, 2020
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
20
Review Days
108
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Basic Information
- Device Name
- OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
- K Number
- K201803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OSSIO , Ltd.
- Date Received
- June 30, 2020
- Decision Date
- October 16, 2020
- Product Code
- HTY
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by OSSIO , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | May 1, 2026 | Substantially Equivalent |
| K254055 | OSSIOfiber® Suture Anchor | Feb 24, 2026 | Substantially Equivalent |
| K252022 | OSSIOfiber® Interference Screw | Aug 19, 2025 | Substantially Equivalent |
| K251309 | OSSIOfiber® Suture Anchor | May 27, 2025 | Substantially Equivalent |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | Apr 3, 2025 | Substantially Equivalent |
| K241932 | OSSIOfiber® Compression Staple | Aug 28, 2024 | Substantially Equivalent |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | Jul 3, 2024 | Substantially Equivalent |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | Mar 8, 2024 | Substantially Equivalent |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | Dec 1, 2023 | Substantially Equivalent |
| K233302 | OSSIOfiber® Compression Staple | Nov 16, 2023 | Substantially Equivalent |