SYNERGY BIOMEDICAL

FDA Device Registration & Listing · Wayne, PA, US · Registration 3010258202

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010258202
FEI Number
3010258202
Entity Name
SYNERGY BIOMEDICAL
City/State/Country
Wayne, PA, US
Establishment Address
565 E. Swedesford Rd, Suite 310, Wayne, PA 19087, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Synergy Biomedical (Owner Number: 10044250)
Owner / Operator Contact Address
565 E. Swedesford Rd, Suite 310, Wayne, PA 19087, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173301
PMA Number
N/A

All Registered Proprietary Names

BioSphere Putty Bioactive Bone Graft BioSphere MIS

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 2014-10-29
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-02-09

Official Correspondent

Matt Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Synergy Biomedical
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

Similar Registrations

Registration Number Establishment Name Location
3007738819 OSferionBiomaterials Corp. Mishima Factory Sunto-gun Shizuoka, JP
3019403037 HERAEUS MEDICAL LLC - BIORESOBABLES Yardley, PA, US
3010376334 GEV Co., Ltd. Eumseong-gun Chungbuk, KR
3043620406 REVOGEN BIOLOGICS San Antonio, TX, US
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010258202. Last updated year: 2026. Please use registration number 3010258202 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.