Medical Device Manufacturer · TW , Taipei

Paonan Biotech Co., Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2017

Recent clearances: NEST-C Interbody System, PK High Tibial Osteotomy Correction System, NEST Interbody System

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Paonan Biotech Co., Ltd. Orthopedic ✕

6 devices
1-6 of 6
Cleared Apr 24, 2023
NEST-C Interbody System
K220261 · ODP
Orthopedic · 448d
Cleared Jun 20, 2019
PK High Tibial Osteotomy Correction System
K182285 · KTW
Orthopedic · 301d
Cleared Jan 25, 2019
NEST Interbody System
K180230 · MAX
Orthopedic · 364d
Cleared Jan 11, 2019
II-Type Intervertebral Spacer
K180228 · MAX
Orthopedic · 350d
Cleared Jul 25, 2018
TREND II Spinal Fixation System- STEP Series
K180226 · NKB
Orthopedic · 180d
Cleared Aug 11, 2017
Paonan Armstrong Posterior Spinal Fixation System
K161225 · NKB
Orthopedic · 452d
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