Data / Medical devices / Israel / Ortho-Space Ltd.
Ortho-Space Ltd.: FDA-registered device maker in Caesarea Haifa, Israel, 1 510(k) clearance
Ortho-Space Ltd. is registered with the FDA (registration 3016573902) in Caesarea Haifa, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2021. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016573902
- Address
- 7 Halamish St, Caesarea Haifa, Israel, 3079579
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 21, 2021
- Registered through
- 2027
- Brand names listed
- InSpace US Large, InSpace US Medium, InSpace US Small
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed | QPQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 12, 2021 | DEN200039 | InSpace Subacromial Tissue Spacer System | QPQ | Unknown | Ortho-Space , Ltd. | accessdata.fda.gov |
Updated July 12, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.