Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030966822

FEI Number

3030966822

Entity Name

BioDynamik

City/State/Country

Lake Forest, CA, US

Establishment Address

11 Orchard Ste 107, Lake Forest, CA 92630, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

BioDynamik, Inc (Owner Number: 10091366)

Owner / Operator Contact Address

11 Orchard Rd, Suite 107, Lake Forest, CA 92630, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PERIOSTEAL ELEVATOR LOCKING BOLT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-01-27
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2025-01-27
HWT	Template	Orthopedic	Class 1	888.4800	2025-04-02
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2024-09-06
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-11-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-04-02
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2025-04-02

Official Correspondent

Johnny Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioDynamik, Inc

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
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3044090645	MEDUSA ORTHOPEDICS, LLC	Fleetwood, PA, US
3021680719	QUALITEX NE LLC	Columbia City, IN, US
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015869121	Jabil Switzerland Manufacturing GmbH (Raron)	Raron Valais, CH
1043653	ONYX MEDICAL LLC	MEMPHIS, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030966822. Last updated year: 2026. Please use registration number 3030966822 when referencing this establishment in official correspondence.