Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000655211

FEI Number

1000655211

Entity Name

Pivot Hawks Manila, Inc.

City/State/Country

Sta Rosa Laguna, PH

Establishment Address

Lot 3-D, Unit 1-3, Greenfield Auto Park SEZ, Barangay Don Jose, Sta Rosa Laguna 4026, PH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Pivot International (Owner Number: 9107199)

Owner / Operator Contact Address

Pivot International, 11030 Strang Line Road, Lenexa, KS 66215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Keepr WalterLorenz Surgical Assist Arm PAL Console 5020

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2010-05-13
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2025-04-23
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2018-07-19
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2011-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

Darshan Bhaiya Business: MAE Group Email: darshanb@maegroups.com Phone: (603) 5050730

Related Public Records

Same Entity

Pivot International

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
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01

Similar Registrations

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3012447612	Highridge Medical, LLC	Westminster, CO, US
1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
3013493300	Devroye Instruments SRL	Etterbeek Brussels-Capital Region, BE
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000655211. Last updated year: 2026. Please use registration number 1000655211 when referencing this establishment in official correspondence.