Data / Medical devices / United States / Synergy Biomedical
Synergy Biomedical: FDA-registered device maker in Wayne, PA, United States, 4 510(k) clearances
Synergy Biomedical is registered with the FDA (registration 3010258202) in Wayne, PA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 12, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010258202
- Address
- 565 E. Swedesford Rd Suite 310, Wayne, PA, United States, 19087
- Owner or operator
- Synergy Biomedical (10044250)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 17, 2013
- Registered through
- 2026
- Brand names listed
- BioSphere Flex, BioSphere MIS, BioSphere Putty Bioactive Bone Graft
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 12, 2018 | K173424 | BioSphere Flex | MQV | Substantially Equivalent | Synergy Biomedical | accessdata.fda.gov |
| January 19, 2018 | K173301 | BioSphere MIS Putty (BioSphere MIS) | MQV | Substantially Equivalent | Synergy Biomedical, LLC | accessdata.fda.gov |
| July 16, 2014 | K140844 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC | MQV | Substantially Equivalent | Synergy Biomedical, Inc. | accessdata.fda.gov |
| April 19, 2013 | K122868 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY | MQV | Substantially Equivalent | Synergy Biomedical, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2018. 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.