Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013681878

FEI Number

3013681878

Entity Name

KOMETABIO INC

City/State/Country

Fort Lee, NJ, US

Establishment Address

One Bridge Plaza North, Suite 275, Fort Lee, NJ 07024, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

KOMETABIO INC (Owner Number: 10054541)

Owner / Operator Contact Address

51 6TH STREET, Cresskill, NJ 07626, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smart Grinder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2018-05-30

Official Correspondent

Amit Binderman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KOMETABIO INC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013681878. Last updated year: 2026. Please use registration number 3013681878 when referencing this establishment in official correspondence.