Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008236846

FEI Number

3008236846

Entity Name

KEYSTONE MANUFACTURING

City/State/Country

Kalamazoo, MI, US

Establishment Address

6387 Technology Ave Ste B, Kalamazoo, MI 49009, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Keystone Manufacturing, LLC (Owner Number: 10031160)

Owner / Operator Contact Address

6387 Technology Avenue, Suite B, Kalamazoo, MI 49009, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FastGrafter Lapiplasty C2Dx Intra-Compartmental Pressure Monitor System SpeedRelease

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-05-04
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-07-25
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-12-15
LXC	Monitor, Pressure, Intracompartmental	Unknown	Class U	N/A	2019-10-31
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-04-09
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2022-11-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-04-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-08
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2020-08-03
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-11-16
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-02-04
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2022-11-14
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-11-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-03-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-09-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-09-25
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-09-25
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-06-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-06-22
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2022-11-16
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2012-07-20
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-12-15
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2023-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Keystone Manufacturing, LLC

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008236846. Last updated year: 2026. Please use registration number 3008236846 when referencing this establishment in official correspondence.