Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010146686

FEI Number

3008808182

Entity Name

Community Blood Center dba Solvita

City/State/Country

Kettering, OH, US

Establishment Address

2900 College Drive, Kettering, OH 45420, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Community Blood Center dba Community Tissue Services (Owner Number: 10045048)

Owner / Operator Contact Address

349 S Main Street, Dayton, OH 45402, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pre-sutured lateral ankle tendon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-09-19

Official Correspondent

Patricia Malone

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Community Blood Center dba Community Tissue Services

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
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18

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3014262693	Arthrex (Shanghai) Co., Ltd.	Shanghai, CN
3012358417	Arthrocare Corporation	Coyol Alajuela, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010146686. Last updated year: 2026. Please use registration number 3010146686 when referencing this establishment in official correspondence.