BIOMET UK LTD.

Registration Details

Registration Name: BIOMET UK LTD.
Registration Number: 3002806535
FEI Number: 3002806535
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: WATERTON INDUSTRIAL ESTATE
City: BRIDGEND
Country: GB

Regulatory Submissions

510(k) Number: K200959
PMA Number: P010014

Owner / Operator

Firm Name: Biomet, Inc.
Operator Number: 1825034
Address: 56 East Bell Dr., PO Box 587
City: Warsaw
State: IN
Postal Code: 46582
Country: US

US Agent

Business Name: Zimmer Biomet
Contact Name: Stephanie Lynch
Address: 1800 W Center St
City: Warsaw
State: IN
ZIP: 46580
Country: US
Email: [email protected]
Phone: 715 9289253

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Driver, Prosthesis	HWR	Class 1	Orthopedic	No	1977-12-28
Osteotome	HWM	Class 1	General, Plastic Surgery	No	2003-12-17
Awl	HWJ	Class 1	Orthopedic	No	1977-12-28
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	MAY	Class 2	Orthopedic	No	2020-08-18
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	Class 2	Orthopedic	No	2020-08-18
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	Class 2	Orthopedic	No	2020-08-18
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	OQH	Class 2	Orthopedic	No	2020-08-18
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	Class 2	Orthopedic	No	2020-08-18
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	OQG	Class 2	Orthopedic	No	2020-08-18
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	Class 2	Orthopedic	No	2020-08-18
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	OQI	Class 2	Orthopedic	No	2020-08-18
Template	HWT	Class 1	Orthopedic	No	1977-12-28
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	Class 2	Orthopedic	No	2012-03-26
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	JDL	Class 3	Orthopedic	No	2012-03-26
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	Class 2	Orthopedic	No	2012-03-26
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	Class 2	Orthopedic	No	2012-03-26
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	KWA	Class 3	Orthopedic	No	2012-03-26
Guide, Surgical, Instrument	FZX	Class 1	General, Plastic Surgery	No	1998-08-27
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing	NRA	Class 3	Unknown	No	2006-05-19
Retractor	GAD	Class 1	General, Plastic Surgery	No	1977-12-28
Tray, Surgical, Instrument	FSM	Class 1	General, Plastic Surgery	No	1992-12-08
Impactor	HWA	Class 1	Orthopedic	No	1977-12-28
Instrument, Cutting, Orthopedic	HTZ	Class 1	General, Plastic Surgery	No	1998-08-27
Orthopedic Manual Surgical Instrument	LXH	Class 1	Orthopedic	No	2003-01-08
Bit, Drill	HTW	Class 1	Orthopedic	No	1977-12-28

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 SURGICAL INSTRUMENT BIOMET TRAY, G7 Dual Mobility System BIOMET IMPACTOR ORTHOPEDIC CUTTING INSTRUMENT BIOMET GENERAL ORTHOPEDIC MANUAL INSTRUMENT BIOMET DRILL BIT

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility