DEPUY CMW

FDA Device Registration & Listing · BLACKPOOL, LANCASHIRE, GB · Registration 9610921

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
9610921
FEI Number
3002806724
Entity Name
DEPUY CMW
City/State/Country
BLACKPOOL, LANCASHIRE, GB
Establishment Address
CORNFORD RD., BLACKPOOL, LANCASHIRE FY4 4QQ, GB
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
DePuy Synthes, Inc. (Owner Number: 1818910)
Owner / Operator Contact Address
700 Orthopaedic Drive, Warsaw, IN 46582, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K071927
PMA Number
N/A

All Registered Proprietary Names

MIXER CEMENT FOR CLINICAL USE (MULTIPLE BRANDS) Vertebroplastic Radiopaque Bone Cement Cemvac Confidence High Viscosity Spinal Cement SmartSet Aneuroplastic SmartSet Bone Cement Conduit TCP Granules Bone Cement Rapid Resorb. Cranial Clamp DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM SmartSet Orthomesh Bone Cement Smartset (bone cement) Vertebroplastic Radiopaque Bone Cement Smartset (bone cement) various cement dispensers TELIGEN SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY SmartSet EVACUATOR VAPOR CEMENT MONOMER (MULTIPLE BRANDS) VACU-MIX PUMP Vertebroplastic Radiopaque Bone Cement

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2001-08-11
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2008-01-21
LOD Bone Cement Orthopedic Class 2 888.3027 2007-12-04
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2015-07-23
LOD Bone Cement Orthopedic Class 2 888.3027 2007-12-04
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-11-21
GXP Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2025-11-21
JXH Methyl Methacrylate For Aneurysmorrhaphy Neurology Class 2 882.5030 2009-07-22
LOD Bone Cement Orthopedic Class 2 888.3027 2007-12-04
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2007-12-04
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2007-12-04
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-07-23
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2007-12-04
LOD Bone Cement Orthopedic Class 2 888.3027 2007-12-04
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2023-08-17
GXR Cover, Burr Hole Neurology Class 2 882.5250 2023-08-17
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2023-08-17
JEY Plate, Bone Dental Class 2 872.4760 2023-08-17
LOD Bone Cement Orthopedic Class 2 888.3027 2026-06-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-06-15
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2026-06-15
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2026-06-15
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2007-12-04
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2007-12-04
LOD Bone Cement Orthopedic Class 2 888.3027 2007-12-04
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2007-12-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-08-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-08-17
LOD Bone Cement Orthopedic Class 2 888.3027 2007-12-04
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2008-06-19
LOD Bone Cement Orthopedic Class 2 888.3027 2008-06-19
JXH Methyl Methacrylate For Aneurysmorrhaphy Neurology Class 2 882.5030 2009-07-22
LOD Bone Cement Orthopedic Class 2 888.3027 2008-06-19
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2004-03-26
JEY Plate, Bone Dental Class 2 872.4760 2023-08-17
LOD Bone Cement Orthopedic Class 2 888.3027 2007-12-04
JDY Evacuator, Vapor, Cement Monomer Orthopedic Class 1 888.4220 1978-03-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2008-01-21
LOD Bone Cement Orthopedic Class 2 888.3027 2008-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

Patrick McCullagh Business: DePuy Synthes Email: pmccull1@its.jnj.com Phone: (267) 3005417

Related Public Records

Same Entity

DePuy Synthes, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009421413 GMED Healthcare BV (a Johnson & Johnson Company) Leeds, GB
3004715683 Memphis Logistic Center Memphis, TN, US
3015516266 Depuy Ireland UC Co. Cork Munster, IE
1219655 DEPUY ORTHOPAEDICS, INC. RAYNHAM, MA, US
3004464325 DEPUY ORTHOPAEDICS BRIDGEWATER, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610921. Last updated year: 2026. Please use registration number 9610921 when referencing this establishment in official correspondence.
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