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Paonan Biotech Co., Ltd: FDA-registered device maker in Taipei, Taiwan, 7 510(k) clearances

Name: Paonan Biotech Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Paonan Biotech Co., Ltd is registered with the FDA (registration 3007887127) in Taipei, Taiwan. It lists 21 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 24, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Paonan Biotech Co., Ltd

FDA registration number: 3007887127
Address: 3F, No.50, Lane.258, Rueiguang Rd., Neihu District, Taipei, Taiwan, 114062
Owner or operator: Paonan Biotech Co., Ltd. (10055949)
Roles: Manufacturer
First device listed: November 14, 2017
Registered through: 2026
Brand names listed: Awl, Bender, Biomech, Length Trial, Nest-C Interbody System, PK High Tibial Osteotomy Correction System, Paonan, Probe and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	KTW	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Manufacturer	accessdata.fda.gov
Bender	HXW	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 24, 2023	K220261	NEST-C Interbody System	ODP	Substantially Equivalent	Paonan Biotech Co., Ltd.	accessdata.fda.gov
June 20, 2019	K182285	PK High Tibial Osteotomy Correction System	KTW	Substantially Equivalent	Paonan Biotech Co., Ltd.	accessdata.fda.gov
January 25, 2019	K180230	NEST Interbody System	MAX	Substantially Equivalent	Paonan Biotech Co., Ltd.	accessdata.fda.gov
January 11, 2019	K180228	II-Type Intervertebral Spacer	MAX	Substantially Equivalent	Paonan Biotech Co., Ltd.	accessdata.fda.gov
July 25, 2018	K180226	TREND II Spinal Fixation System- STEP Series	NKB	Substantially Equivalent	Paonan Biotech Co., Ltd.	accessdata.fda.gov
August 11, 2017	K161225	Paonan Armstrong Posterior Spinal Fixation System	NKB	Substantially Equivalent	Paonan Biotech Co., Ltd.	accessdata.fda.gov
July 3, 2006	K051704	MYKRES SPINAL SYSTEM	MNI	Substantially Equivalent	Showa Ika Kohgyo Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.