Paonan Biotech Co., Ltd
Taipei, TW
PAONAN BIOTECH CO., LTD appears in FDA device records in Taipei, TW. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Paonan Biotech Co., Ltd between 2017 and 2023. The busiest year on record is 2019, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220261 | NEST-C Interbody System | ODP | Substantially Equivalent | |
| K182285 | PK High Tibial Osteotomy Correction System | KTW | Substantially Equivalent | |
| K180230 | NEST Interbody System | MAX | Substantially Equivalent | |
| K180228 | II-Type Intervertebral Spacer | MAX | Substantially Equivalent | |
| K180226 | TREND II Spinal Fixation System- STEP Series | NKB | Substantially Equivalent | |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007887127 | 3007887127 | PAONAN BIOTECH CO., LTD | 3F, No.50, Lane.258, Rueiguang Rd., Neihu District, Taipei 114062 TW | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- KWPAppliance, Fixation, Spinal Interlaminal
- HWJAwl
- HXWBender
- HTJGauge, Depth
- HXPInstrument, Bending Or Contouring
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- JDWPin, Fixation, Threaded
- HXBProbe
- HXOPusher, Socket
- HXXScrewdriver
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Paonan Biotech Co., Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain