Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000199132

FEI Number

3000199132

Entity Name

BOEDEKER PLASTICS, INC.

City/State/Country

SHINER, TX, US

Establishment Address

904 W 6th St, SHINER, TX 77984, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BOEDEKER PLASTICS, INC. (Owner Number: 9069127)

Owner / Operator Contact Address

904 WEST 6TH ST., --, Shiner, TX 77984, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

30474 306.618 60.51113 306.742 306.614 03.100.356 306.781 306.610 60.511.112 60.511.115 306.521 306.789 60.511.109 60.51110 60.44905 306.613 60.51111 30471 306.760 03.54004 03.100.348 306.640 306.779 60.51001 60.511.111 60.511.105 60.50307 306.755 03.100.344 306.778 60.51002 306.512 306.748 60.51106 60.50306 03.100.342 60.51108 60.511.108 306.510 306.749 306.784 60.511.107 306.617 03.100.358 60.50308 03.100.346 306.745 306.772 306.782 306.642 30472 306.619 30489 03.100.354 30495 60.511.113 60.51109 306.624 306.747 306.761 306.505 306.611 60.511.114 305.698 306.787 306.757 60.51103 306.746 60.511.110 306.740 306.570 306.785 60.511.106 60.51104 306.502 306.783 60.51105 306.741 306.616 306.620 03.100.352 306.770 306.507 306.743 306.752 03.100.350 30473 306.573 60.31500 60.51112 60.50305 306.615 306.501 306.786 60.50312 TEMPLATE 310-99-105 310-99-107 212-00-001 112-00-001 310-01-102 214-00-001 210-00-001 510-99-101 330-01-204 311-99-011 112-00-006 111-00-001 214-99-004 320-01-104 320-01-103 320-99-112 317-00-001 317-99-011 212-99-011 330-01-208 320-01-102 510-00-001 310-01-103 330-01-206 320-01-101 330-01-205 210-99-011 310-01-101 330-01-207 311-00-001 310-01-104 330-01-209

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-30
HWT	Template	Orthopedic	Class 1	888.4800	2017-04-13
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-09-02

Official Correspondent

MICHAEL RAINDL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BOEDEKER PLASTICS, 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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3012574325	HAKAMA AG	Baettwil Solothurn, CH
3001397320	ROECHLING MEDICAL ROCHESTER L.P.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000199132. Last updated year: 2026. Please use registration number 3000199132 when referencing this establishment in official correspondence.