NEST Interbody System— 510(k) K180230

Clearance details

Applicant

Paonan Biotech Co., Ltd.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2018-01-26

Decision date

2019-01-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taipei City 114, TW

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K220261 — NEST-C Interbody System2023-04-24
• K182285 — PK High Tibial Osteotomy Correction System2019-06-20
• K180228 — II-Type Intervertebral Spacer2019-01-11
• K180226 — TREND II Spinal Fixation System- STEP Series2018-07-25
• K161225 — Paonan Armstrong Posterior Spinal Fixation System2017-08-11

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →