Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016573902

FEI Number

3016573902

Entity Name

Ortho-Space Ltd.

City/State/Country

Caesarea Haifa, IL

Establishment Address

7 Halamish St, Caesarea Haifa 3079579, IL

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN200039

PMA Number

N/A

All Registered Proprietary Names

InSpace US Small InSpace US Medium InSpace US Large

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QPQ	Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed	Orthopedic	Class 2	888.3630	2021-07-21

Official Correspondent

No official correspondent registered.

US Agent Details

April Malmborg Business: Stryker Endoscopy Email: april.malmborg@stryker.com Phone: (408) 4093115

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3010411911	POM Medical, LLC	Moorpark, CA, US
8010153	BERCHTOLD GMBH & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE

Similar Registrations

Registration Number	Establishment Name	Location
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL
2936485	STRYKER ENDOSCOPY	SAN JOSE, CA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016573902. Last updated year: 2026. Please use registration number 3016573902 when referencing this establishment in official correspondence.