Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007887127

FEI Number

3007887127

Entity Name

PAONAN BIOTECH CO., LTD

City/State/Country

Taipei, TW

Establishment Address

3F, No.50, Lane.258, Rueiguang Rd., Neihu District, Taipei 114062, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Paonan Biotech Co., Ltd. (Owner Number: 10055949)

Owner / Operator Contact Address

3F, No.50, Lane.258, Rueiguang Rd., Neihu District,, Taipei, TW-TPE 114062, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220261

PMA Number

N/A

All Registered Proprietary Names

Paonan Biomech Taps Awl Probe Rod Pusher Biomech Paonan Bender PK High Tibial Osteotomy Correction System TEMPLATE Biomech TREND Surgical Instrument System TREND II Surgical Instrument System Paonan Paonan Biomech Wrench Nest-C Interbody System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-08-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-11-14
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2024-02-02
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2019-07-12
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2024-02-02
HWJ	Awl	Orthopedic	Class 1	888.4540	2019-07-12
HXB	Probe	Orthopedic	Class 1	888.4540	2019-07-12
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2019-07-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-01-14
HXW	Bender	Orthopedic	Class 1	888.4540	2019-07-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-02-22
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2019-06-27
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2019-06-27
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-06-27
HWT	Template	Orthopedic	Class 1	888.4800	2019-07-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-07-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-02-25
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-07-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-10-30

Official Correspondent

North Zhong

US Agent Details

Travis Hsu Business: Qualtech Consulting LLC Email: travis@qualtechs.com Phone: (626) 3455899

Related Public Records

Same Entity

Paonan Biotech Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

Similar Registrations

Registration Number	Establishment Name	Location
3043234953	ALLUMIN8 INC	Springfield, MO, US
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3004635447	C&W SWISS, INC.	CLAYTON, OH, US
3015869493	Jabil Switzerland Manufacturing GmbH (Mezzovico)	Mezzovico Ticino, CH
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007887127. Last updated year: 2026. Please use registration number 3007887127 when referencing this establishment in official correspondence.