Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009790163

FEI Number

3009790163

Entity Name

AEGIS MEDITEC, INC.

City/State/Country

Costa Mesa, CA, US

Establishment Address

130 McCormick Ave, Suite 106, Costa Mesa, CA 92626, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Aegis Spine (Owner Number: 10031416)

Owner / Operator Contact Address

130 McCormick Ave, Suite 106, Costa Mesa, CA 92626, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bone Screw Starter Fork Impactor Corkscrew ZESPIN SI Joint Fusion System Paeon Anterior Cervical Plate System Paeon Posterior Cervical Fixation System Elatus Lumbar Plate System ABTross ALIF Expandable Cage System Tamp Dissector Burr TRAY, SURGICAL, INSTRUMENT Paeon Anterior Cervical Plate System Elatus Lumbar Plate System Wire Cutter Orthopedic Surgical Scissors Elatus Lumbar Plate System Paeon Anterior Cervical Plate System Paeon Posterior Cervical Fixation System ZESPINE SI Joint Fusion System ZESPIN SI Joint Fusion System Bender Compressor Tap Wrench File Knife Guide Wire Surgical Stripper Rongeur Reamer Guide, surgical, instrument CALIPER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2021-02-09
HXE	Fork	Orthopedic	Class 1	888.4540	2021-02-09
HWA	Impactor	Orthopedic	Class 1	888.4540	2021-02-09
HWI	Corkscrew	Orthopedic	Class 1	888.4540	2021-02-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-02-09
HXG	Tamp	Orthopedic	Class 1	888.4540	2021-02-09
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-04-01
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2021-02-09
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-09-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-01-25
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2021-02-09
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2021-02-09
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-02-23
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2021-02-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-02-23
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2021-02-23
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-01-25
HXW	Bender	Orthopedic	Class 1	888.4540	2021-02-09
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2021-02-09
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2021-02-09
HXC	Wrench	Orthopedic	Class 1	888.4540	2021-02-09
HTP	File	Orthopedic	Class 1	888.4540	2021-02-09
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2021-02-09
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2021-02-09
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2021-02-09
HTX	Rongeur	Orthopedic	Class 1	888.4540	2021-02-09
HTO	Reamer	Orthopedic	Class 1	888.4540	2021-02-09
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-09-10
KTZ	Caliper	Orthopedic	Class 1	888.4150	2021-09-10

Official Correspondent

Tony Ahn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aegis Spine

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
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K161478	Xenco Medical, LLC	Xenco Medical Posterior Cervical System	2016-09-06
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number	Establishment Name	Location
3007125392	Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou Guangdong, CN
1043534	WRIGHT MEDICAL TECHNOLOGY, INC.	Arlington, TN, US
3024706750	KERI MEDICAL	Plan-les-Ouates Geneve, CH
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
1647149	Steritec Services, LLC	ATHENS, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009790163. Last updated year: 2026. Please use registration number 3009790163 when referencing this establishment in official correspondence.