FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SPINAUT-P
K Number: K150915
·
Decision Mar 18, 2016
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
347
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Basic Information
- Device Name
- SPINAUT-P
- K Number
- K150915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imedicom Co., Ltd.
- Date Received
- April 6, 2015
- Decision Date
- March 18, 2016
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Imedicom Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K182287 | MEDINAUT Plus | Apr 6, 2019 | Substantially Equivalent |
| K173541 | EPINAUT | Aug 24, 2018 | Substantially Equivalent |
| K153296 | MEDINAUT Kyphoplasty System | Jul 29, 2016 | Substantially Equivalent |
| K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | Mar 16, 2016 | Substantially Equivalent |
| K150789 | SPINAUT-E, SPINAUT-I | Mar 1, 2016 | Substantially Equivalent |