Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040266825

FEI Number

3040266825

Entity Name

DEMETRA, INC.

City/State/Country

Germantown, TN, US

Establishment Address

6800 Poplar Ave Ste 120, Germantown, TN 38138, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Demetra, Inc. (Owner Number: 10093966)

Owner / Operator Contact Address

6800 Poplar Ave, Ste 120, Germantown, TN 38138, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TAILORED-C DEMETRA SPINE INSTRUMENTS DEMETRA SPINE INSTRUMENTS DEMETRA SPINE INSTRUMENTS DEMETRA SPINE INSTRUMENTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-08-25
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-08-25
HWJ	Awl	Orthopedic	Class 1	888.4540	2025-08-25
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-08-25
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-08-25

Official Correspondent

Katie Taylor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Demetra, 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
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25

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
3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040266825. Last updated year: 2026. Please use registration number 3040266825 when referencing this establishment in official correspondence.