FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
SMARTO
K Number: K101563
·
Decision Dec 17, 2010
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
28
Applicant Total
18
Review Days
196
Basic Information
- Device Name
- SMARTO
- K Number
- K101563
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JEIL MEDICAL CORPORATION
- Date Received
- June 4, 2010
- Decision Date
- December 17, 2010
- Product Code
- KIJ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by JEIL MEDICAL CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K161335 | Dual Top Screw System | Feb 23, 2017 | Substantially Equivalent |
| K163308 | SMARTO | Dec 27, 2016 | Substantially Equivalent |
| K161864 | ARIX Foot System | Aug 2, 2016 | Substantially Equivalent |
| K143730 | GBR System | Jun 10, 2015 | Substantially Equivalent |
| K141452 | LEFORTE NEURO SYSTEM BONE PLATE AND SCREW | Jul 2, 2014 | Substantially Equivalent |
| K132876 | ARIX HAND LOCKING SYSTEM | Dec 18, 2013 | Substantially Equivalent |
| K131566 | ARIX HAND SYSTEM | Nov 4, 2013 | Substantially Equivalent |
| K131311 | ARIX FOOT SYSTEM | Sep 5, 2013 | Substantially Equivalent |
| K112812 | LEFORTE NEURO SYSTEM BONE PLATE | Feb 22, 2012 | Substantially Equivalent |
| K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 | Feb 8, 2011 | Substantially Equivalent |