Data / Medical devices / United States / Boylston Surgical LLC
Boylston Surgical LLC: FDA-registered device maker in Osterville, MA, United States, 3 510(k) clearances
Boylston Surgical LLC is registered with the FDA (registration 3033302333) in Osterville, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 6, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033302333
- Address
- 97 1st Ave, Osterville, MA, United States, 02655
- Owner or operator
- Boylston Surgical LLC (10091794)
- Roles
- Specification developer
- First device listed
- November 1, 2024
- Registered through
- 2026
- Brand names listed
- X-Repair, X-RepairSL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | 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 |
|---|---|---|---|---|---|---|
| August 6, 2014 | K141394 | X-REPAIR | FTL | Substantially Equivalent | Synthasome | accessdata.fda.gov |
| July 2, 2014 | K141499 | X-REPAIRSL | FTL | Substantially Equivalent | Synthasome, Inc. | accessdata.fda.gov |
| March 27, 2009 | K083307 | SYNTHASOME X-REPAIR | FTL | Substantially Equivalent | Synthasome, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Polymeric
- All makers of Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Updated August 6, 2014. 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.