Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004579081

FEI Number

3004579081

Entity Name

MEMRY CORPORATION

City/State/Country

Bethel, CT, US

Establishment Address

3 Berkshire Blvd, Bethel, CT 06801, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Resonetics, LLC (Owner Number: 10078190)

Owner / Operator Contact Address

26 Whipple Street, Nashua, NH 03060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline UNITE REFLEX Dynamic Discs Orthopedic manual surgical instrument JDR - Staple, fixation, bone Medline UNITE REFLEX Nitinol Staple System Medline UNITE® REFLEX® Hybrid Nitinol Implant System Medline UNITE REFLEX Nitinol Staple STAPLE, FIXATION, BONE Arthrex FiberTak Suture Anchor Stylet for Catheter, Gastro-Urology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-11-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-01-09
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-08-20
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-04-15
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-04-15
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-11-08
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2024-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Resonetics, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011752740	AGILE MV	Montreal Quebec, CA
3015192261	Resonetics, LLC	Or Akiva Central, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3003604053	SMITH & NEPHEW INC.	ANDOVER, MA, US
3008870565	Implant Logistics / AMS Micromedical	Sparta, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004579081. Last updated year: 2026. Please use registration number 3004579081 when referencing this establishment in official correspondence.