Paonan Biotech Co., Ltd.
FDA Regulatory Profile
Paonan Biotech Co., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Feb 7, 2025 · OAI
- Latest 510(k)
- Apr 24, 2023
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 6 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Feb 7, 2025 | Taipei City, Taiwan | Devices | Official Action Indicated (OAI) | 3007887127 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3007887127 | Taipei City, Taiwan | 1 | Feb 7, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220261 | NEST-C Interbody System | Apr 24, 2023 |
| K182285 | PK High Tibial Osteotomy Correction System | Jun 20, 2019 |
| K180230 | NEST Interbody System | Jan 25, 2019 |
| K180228 | II-Type Intervertebral Spacer | Jan 11, 2019 |
| K180226 | TREND II Spinal Fixation System- STEP Series | Jul 25, 2018 |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | Aug 11, 2017 |