Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027754

FEI Number

2027754

Entity Name

OSTEOMED

City/State/Country

ADDISON, TX, US

Establishment Address

3885 Arapaho Rd, ADDISON, TX 75001, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSTEOMED (Owner Number: 9000613)

Owner / Operator Contact Address

3885 Arapaho Rd., --, Addison, TX 75001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062863

PMA Number

N/A

All Registered Proprietary Names

Goniometer Sharp Hook Compressor Instrument Ring Curette Cup Curette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-16
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2001-06-19
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-12-30
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2014-12-30
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2014-12-30
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2007-10-31
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2007-10-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
HWA	Impactor	Orthopedic	Class 1	888.4540	2014-12-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-31
HXX	Screwdriver	Orthopedic	Class 1	888.4540	1992-10-02
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-12-29
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2007-10-31
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2007-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-31
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2001-09-28
JEY	Plate, Bone	Dental	Class 2	872.4760	2007-10-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-10-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-10-29
JEY	Plate, Bone	Dental	Class 2	872.4760	2007-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-05-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-05-19
JEY	Plate, Bone	Dental	Class 2	872.4760	2015-06-10
JEY	Plate, Bone	Dental	Class 2	872.4760	2026-04-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-12-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-12-16
HTO	Reamer	Orthopedic	Class 1	888.4540	2014-12-30
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-12-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-21
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-12-30
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2015-09-22
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2001-06-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-08-11
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2001-06-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-12-18
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2007-10-31
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-01-27
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2017-04-19
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2017-04-19
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-12-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-12-16
LZJ	Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained	Unknown	Class U	N/A	2007-10-31
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2007-10-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-04-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-04-12
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2008-11-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-10-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-10-29
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-12-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2026-04-02
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2014-12-30
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2007-10-31
HXW	Bender	Orthopedic	Class 1	888.4540	2001-06-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-16
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2026-04-02
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2018-07-23
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2014-12-30
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2007-10-31
MQN	External Mandibular Fixator And/Or Distractor	Dental	Class 2	872.4760	2007-10-31
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-01-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-31
HTP	File	Orthopedic	Class 1	888.4540	2014-12-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-08-17
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-08-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-08-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-31
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2014-12-30
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2007-10-31
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2007-10-31
PBJ	Cranial Distraction System	Neurology	Class 2	882.5330	2013-12-16
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2013-12-16
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2007-10-31
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-12-21
HWT	Template	Orthopedic	Class 1	888.4800	2001-06-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-06-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-31
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-12-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2026-04-02
NEI	Prosthesis, Condyle, Mandibular, Temporary	Dental	Class 2	872.4770	2007-05-25
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2001-06-19
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2011-12-13
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2011-12-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-04-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2017-04-28
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2001-06-19
HWW	Countersink	Orthopedic	Class 1	888.4540	2001-06-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2004-05-07
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2007-05-16
HTQ	Broach	Orthopedic	Class 1	888.4540	2014-12-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2007-05-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-10-31

Official Correspondent

Kathryn Jayne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSTEOMED

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
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027754. Last updated year: 2026. Please use registration number 2027754 when referencing this establishment in official correspondence.