FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
PK High Tibial Osteotomy Correction System
K Number: K182285
·
Decision Jun 20, 2019
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
6
Review Days
301
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Basic Information
- Device Name
- PK High Tibial Osteotomy Correction System
- K Number
- K182285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paonan Biotech Co., Ltd.
- Date Received
- August 23, 2018
- Decision Date
- June 20, 2019
- Product Code
- KTW
- 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 |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
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Other Clearances by Paonan Biotech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220261 | NEST-C Interbody System | Apr 24, 2023 | Substantially Equivalent |
| K180230 | NEST Interbody System | Jan 25, 2019 | Substantially Equivalent |
| K180228 | II-Type Intervertebral Spacer | Jan 11, 2019 | Substantially Equivalent |
| K180226 | TREND II Spinal Fixation System- STEP Series | Jul 25, 2018 | Substantially Equivalent |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | Aug 11, 2017 | Substantially Equivalent |