FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoLink Sfx Implant System
K Number: K203698
·
Decision May 4, 2021
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
25
Review Days
137
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Basic Information
- Device Name
- CoLink Sfx Implant System
- K Number
- K203698
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- In2bones USA, LLC
- Date Received
- December 18, 2020
- Decision Date
- May 4, 2021
- 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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|---|---|---|---|
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