Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014483751

FEI Number

3014483751

Entity Name

KLS MARTIN MANUFACTURING, LLC

City/State/Country

Jacksonville, FL, US

Establishment Address

11228 Saint Johns Industrial Parkway South, Jacksonville, FL 32246, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KLS Martin Manufacturing, LLC (Owner Number: 10057459)

Owner / Operator Contact Address

11228 Saint Johns Industrial Pkwy S, Jacksonville, FL 32246, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2021-05-10
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2018-05-11
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2018-05-11
HWT	Template	Orthopedic	Class 1	888.4800	2018-04-09
JEY	Plate, Bone	Dental	Class 2	872.4760	2026-03-26
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2026-03-26
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2026-03-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-03-26
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2025-03-18
ELE	Implant, Subperiosteal	Dental	Class 2	872.3645	2022-10-12
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2021-05-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-05-10
PPT	Cranial Surgical Planning And Instrument Guides	Neurology	Class 2	882.4310	2021-05-10
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-01-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-13
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2026-01-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KLS Martin 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
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2

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2916714	AESCULAP, INC.	CENTER VALLEY, PA, US
1057946	KLS-Martin L.P.	Jacksonville, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014483751. Last updated year: 2026. Please use registration number 3014483751 when referencing this establishment in official correspondence.