Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002806535

FEI Number

3002806535

Entity Name

BIOMET UK LTD.

City/State/Country

BRIDGEND, GB

Establishment Address

WATERTON INDUSTRIAL ESTATE, BRIDGEND CF31 3XA, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Biomet, Inc. (Owner Number: 1825034)

Owner / Operator Contact Address

56 East Bell Dr., PO Box 587, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROSTHESIS DRIVER BIOMET BIOMET OSTEOTOME BIOMET AWL Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling BIOMET TEMPLATE ARCOS INTERLOCKING DISTAL STEMS GUIDE BIOMET SURGICIAL OXFORD MENISCAL UNICOM RETRACTOR BIOMET SURGICAL INSTRUMENT BIOMET TRAY, G7 Dual Mobility System BIOMET IMPACTOR BIOMET ORTHOPEDIC CUTTING INSTRUMENT BIOMET GENERAL ORTHOPEDIC MANUAL INSTRUMENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	1977-12-28
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2003-12-17
HWJ	Awl	Orthopedic	Class 1	888.4540	1977-12-28
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2020-08-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-08-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2020-08-18
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2020-08-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-08-18
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2020-08-18
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2020-08-18
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2020-08-18
HWT	Template	Orthopedic	Class 1	888.4800	1977-12-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-03-26
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2012-03-26
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-03-26
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2012-03-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-03-26
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-03-26
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-03-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-03-26
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2012-03-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1998-08-27
NRA	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2006-05-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1977-12-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1992-12-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-06-04
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-06-04
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2015-06-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-06-04
HWA	Impactor	Orthopedic	Class 1	888.4540	1977-12-28
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1998-08-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2003-01-08

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Lynch Business: Zimmer Biomet Email: Stephanie.Lynch@zimmerbiomet.com Phone: (715) 9289253

Related Public Records

Same Entity

Biomet, 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
1216032	Citra Labs LLC	Braintree, MA, US
3006946279	BIOMET FRANCE	Valence Drome, FR
1825034	BIOMET, INC.	WARSAW, IN, US
3006801265	Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, CN
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K983036	Biomet, Inc.	SINGLE AXLE TOTAL ELBOW	1999-04-30
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K921181	Biomet, Inc.	MALLORY-HEAD TOTAL HIP SYSTEM	1994-02-16
K830313	Biomet, Inc.	CFE TOTAL HIP FEMORAL COMPONENT	1983-05-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0032-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Z-0007-2023	Zimmer, Inc.	2	G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002806535. Last updated year: 2026. Please use registration number 3002806535 when referencing this establishment in official correspondence.