Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1650372

FEI Number

3002253367

Entity Name

OSTEOGENICS BIOMEDICAL, INC.

City/State/Country

LUBBOCK, TX, US

Establishment Address

4620 71st St Bldg 78-79, LUBBOCK, TX 79424, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

OSTEOGENICS BIOMEDICAL, INC. (Owner Number: 9028315)

Owner / Operator Contact Address

4620 71ST ST., BLDG. 78-79, --, Lubbock, TX 79424, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162158

PMA Number

N/A

All Registered Proprietary Names

Pro-fix 56 mm Cruciform Driver Blade Pro-Fix Contra Angle Driver Blade Pro-fix 76 mm Cruciform Driver Blade Pro-fix Bone Fixation Screws Pro-fix Membrane Fixation Screws Pro-fix Tenting Screws Pro-fix Precision Fixation System Symbios Collagen Membrane Cytoplast RTM Collagen Membrane Pro-fix Tecapro Storage Tray Osteo-Mesh TM-300 Titanium Mesh Vitala Cytoplast PTFE Sutures RTM Dental Wound Dressings RPM Reinforced PTFE Mesh Pro-fix Driver Handle Cytoplast GBR/TXT d-PTFE Membranes Cytoplast Titanium-Reinforced PTFE Membranes ZCORE porcine xenograft particulate IN SYRINGE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-08-28
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2022-03-23
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2011-06-06
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2023-01-19
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-12-21
JEY	Plate, Bone	Dental	Class 2	872.4760	2007-12-14
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2016-04-29
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2009-03-02
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-12-02
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2018-05-16
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-05-16
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2016-12-21
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2007-12-14
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2007-12-14
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2017-07-11

Official Correspondent

Salem O'Steen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSTEOGENICS BIOMEDICAL, 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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1650372. Last updated year: 2026. Please use registration number 1650372 when referencing this establishment in official correspondence.