Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011015097

FEI Number

3011015097

Entity Name

PROSIDYAN, INC.

City/State/Country

New Providence, NJ, US

Establishment Address

41 Spring Street #107, New Providence, NJ 07974, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Prosidyan, Inc. (Owner Number: 10047049)

Owner / Operator Contact Address

41 Spring Street #107, New Providence, NJ 07974, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251648

PMA Number

N/A

All Registered Proprietary Names

FIBERGRAFT BG PUTTY FIBERGRAFT AERIDYAN Matrix GPS Advanced GPS Advanced Cannula

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	2017-12-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-03-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-08-20

Official Correspondent

Karen Parker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prosidyan, 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
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

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 3011015097. Last updated year: 2026. Please use registration number 3011015097 when referencing this establishment in official correspondence.