Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2530154

FEI Number

1000307073

Entity Name

DSM Biomedical, Inc.

City/State/Country

EXTON, PA, US

Establishment Address

735 Pennsylvania Dr, EXTON, PA 19341, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DSM BIOMEDICAL (Owner Number: 9020253)

Owner / Operator Contact Address

735 PENNSYLVANIA DRIVE, --, Exton, PA 19341, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Meso Wound Matrix xenoPATCH Resolve Matrix Acellular Peritoneum Matrix DSM Biomedical Porcine Pericardium Dental Membrane Medeor Matrix Medeor Tendon Matrix Delivery Needle Meso Tendon Matrix Medeor Tendon Matrix JEN Device DSM Biomedical Calcium Phosphate Cement DSM Dental Bone Graft COPIOS BONE VOID FILLER DSM Dental Bone Graft Plus PEAK PRP System DSM Biomedical PRP Device Meso Dental Membrane

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	2012-11-07
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2012-02-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-08-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2011-12-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-30
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-12-30
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-22
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2016-06-14
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-11-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2011-12-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-08-31
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-11-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-04
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2009-11-10
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2009-11-10
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2009-11-10
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2009-11-10
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2009-11-10
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2009-11-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-01-09
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-07
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2013-01-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-10-11
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-22
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2013-12-30
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2011-07-12
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2011-07-12
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2011-07-12
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2011-07-12
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2011-07-12
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-05
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2015-03-26
QNI	Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair	Orthopedic	Class 2	888.3044	2021-11-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-22
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2009-11-10
NOX	Filler, Bone Void, Synthetic Peptide	Unknown	Class 3	N/A	2025-07-01
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-03-22
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Orthopedic	Class 2	888.3045	2023-03-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-05
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2017-05-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2006-01-26
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2020-09-11
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-12
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2012-11-12
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2016-05-20
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2014-04-14
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2013-07-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-01-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-22
NOX	Filler, Bone Void, Synthetic Peptide	Unknown	Class 3	N/A	2020-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DSM 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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2530154. Last updated year: 2026. Please use registration number 2530154 when referencing this establishment in official correspondence.