Data / Medical devices / Singapore / Osteopore International Pte Ltd
Osteopore International Pte Ltd: FDA-registered device maker in Singapore South West, Singapore, 1 510(k) clearance
Osteopore International Pte Ltd is registered with the FDA (registration 3007303685) in Singapore South West, Singapore. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 17, 2006. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007303685
- Address
- 2 Tukang Innovation Grove, #09-06 JTC MedTech Hub, Singapore South West, Singapore, 618305
- Owner or operator
- Osteopore International Pte Ltd (10027129)
- Roles
- Manufacturer
- First device listed
- October 6, 2008
- Registered through
- 2026
- Brand names listed
- Osteomesh, Osteoplug, Osteoplug-C, Osteostrip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Methyl Methacrylate For Cranioplasty | GXP | 2 | 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 |
|---|---|---|---|---|---|---|
| March 17, 2006 | K051093 | OSTEOPORE PCL SCAFFOLD | GXP | Substantially Equivalent | Osteopore, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2011 | 59231 | Not yet classified | Terminated | Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh. | Product sterility may be compromised. | accessdata.fda.gov |
Compare with other makers
Updated January 11, 2012. 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.