ACCENTUS MEDICAL LTD

FDA Device Registration & Listing · DIDCOT Oxfordshire, GB · Registration 3005913274

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
3005913274
FEI Number
3005913274
Entity Name
ACCENTUS MEDICAL LTD
City/State/Country
DIDCOT Oxfordshire, GB
Establishment Address
528.10 UNIT 2 Rutherford Avenue, Harwell Campus, DIDCOT Oxfordshire OX11 0DF, GB
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Accentus Medical Ltd (Owner Number: 9096541)
Owner / Operator Contact Address
528.10 Unit 2 Rutherford Avenue, Harwell Campus, Didcot, GB-OXF OX11 0DF, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MINIHIP FEMORAL STEM MetaFix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2017-12-13
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2017-12-13
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-02-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-12-13
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2017-12-13
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-01-10
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2020-01-10
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-01-10
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2019-12-20
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2019-12-20
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-04-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2020-01-22
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2020-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Accentus Medical Ltd
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
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10
K932222 Dow Corning Wright SLT FEMORAL HEAD 1994-05-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005913274. Last updated year: 2026. Please use registration number 3005913274 when referencing this establishment in official correspondence.
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