Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038185071

FEI Number

3038185071

Entity Name

OTS-MEDICAL

City/State/Country

Binyamina Haifa, IL

Establishment Address

3 Hamelacha st, Binyamina Haifa 3057324, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OTS-Medical (Owner Number: 10093227)

Owner / Operator Contact Address

3 Hamelacha st., Binyamina, IL-HA 3057324, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233429

PMA Number

N/A

All Registered Proprietary Names

Raphael 25 OTS 25 L OTS 25 L Raphael 25 OTS 25 OTS 25 Raphael 25

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-04-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-07-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-04-15

Official Correspondent

Adely Levy

US Agent Details

Christopher Kawchak Business: Kawchak Ortho Supply LLC Email: chris@ots-medical.com Phone: (814) 2335529

Related Public Records

Same Entity

OTS-Medical

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
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

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3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038185071. Last updated year: 2026. Please use registration number 3038185071 when referencing this establishment in official correspondence.