Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015860552

FEI Number

3015860552

Entity Name

P&F MACHINING

City/State/Country

Otsego, MN, US

Establishment Address

8450 Quaday Ave NE, Otsego, MN 55330, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

P&F Machining (Owner Number: 10061255)

Owner / Operator Contact Address

8450 Quaday Ave NE, Otsego, MN 55330, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133287

PMA Number

N/A

All Registered Proprietary Names

Smith and Nephew Presson Spinal Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-10-03
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2020-10-09
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-10-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

P&F Machining

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
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31

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3001614464	medi-G GMBH	Messkirch Baden-Wurttemberg, DE
3028006458	ClearPoint Neuro Inc.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015860552. Last updated year: 2026. Please use registration number 3015860552 when referencing this establishment in official correspondence.