Paonan Armstrong Posterior Spinal Fixation System
FDA 510(k) clearance K161225 · decided 2017-08-11
Clearance details
- K-number
- K161225
- Device name
- Paonan Armstrong Posterior Spinal Fixation System
- Applicant
- Paonan Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-16
- Decision date
- 2017-08-11
- Days to decision
- 452 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Taipei, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.