FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Accu-Joint Hemi Implant
K Number: K200951
·
Decision Dec 8, 2020
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
2
Review Days
243
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Basic Information
- Device Name
- Accu-Joint Hemi Implant
- K Number
- K200951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Accufix Surgical, Inc.
- Date Received
- April 9, 2020
- Decision Date
- December 8, 2020
- Product Code
- KWD
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Accufix Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240268 | Accu-Joint Hemi Implant | Feb 29, 2024 | Substantially Equivalent |