Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225112

FEI Number

3000206397

Entity Name

ETEX Corporation

City/State/Country

Braintree, MA, US

Establishment Address

55 Messina Dr, Braintree, MA 02184, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zimmer Biomet ETEX (Owner Number: 9014709)

Owner / Operator Contact Address

55 Messina Dr., --, Braintree, MA 02184, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090855

PMA Number

N/A

All Registered Proprietary Names

EquivaBone N-Force Blue Mixing and Delivery System Precision Mixing and Delivery System Etex Mixing and Delivery System Beta BSM Gamma BSM moldable EquivaBone Osteoinductive Bone Graft Substitute Alpha BSM Gamma-BSM EquivaBone Bone Grafting Material Beta-BSM AccuFill; AccuFill PreFill CarriGen PF AccuFill PF Beta BSM ; Flow-FX 2; OssiFuse Bone Substitute Material EquivaBone Osteoinductive Bone Graft Substitute

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2009-04-27
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2009-04-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-12-18
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2010-12-13
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2010-12-13
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2015-10-23
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2015-10-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-11-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-11-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-09-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-09-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-11-07
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2015-10-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-10-23

Official Correspondent

Stephanie Lynch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zimmer Biomet ETEX

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
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225112. Last updated year: 2026. Please use registration number 1225112 when referencing this establishment in official correspondence.