Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010045785

FEI Number

3010045785

Entity Name

MPS Micro Precision Systems AG

City/State/Country

Biel-Bienne Bern, CH

Establishment Address

Chemin du Long-Champ 95, Biel-Bienne Bern 2504, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MPS Micro Precision Systems AG (Owner Number: 10043225)

Owner / Operator Contact Address

Chemin du Long-Champ 95, Biel-Bienne, CH-BE 2504, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Allen key 3.5 mm Broach

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-07-05
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2013-11-22
HWT	Template	Orthopedic	Class 1	888.4800	2016-01-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-07-15
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-03-20
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-03-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-02-05
HTQ	Broach	Orthopedic	Class 1	888.4540	2022-09-28
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2024-07-15
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-02-05
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-03-20
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2015-09-14
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2015-09-14

Official Correspondent

Arnaud BILLOT

US Agent Details

Adrian Keene Business: NAMSA Email: usagentservices@namsa.com Phone: (419) 6668455

Related Public Records

Same Entity

MPS Micro Precision Systems AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3023449169	BEIJING ROSSUMROBOT TECHNOLOGY CO., LTD.	Beijing, CN
3015542154	Zimmer Biomet Korea Ltd.	Seoul, KR
1221934	DePuy Mitek, Inc.	RAYNHAM, MA, US
1000517406	Paragon Medical Inc.	Smithfield, UT, US
3010536692	MICROPORT ORTHOPEDICS INC.	Arlington, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010045785. Last updated year: 2026. Please use registration number 3010045785 when referencing this establishment in official correspondence.