Data / Medical devices / United States / Surgical Fusion Inc.
Surgical Fusion Inc.: FDA-registered device maker in Englewood Cliffs, NJ, United States, 2 510(k) clearances
Surgical Fusion Inc. is registered with the FDA (registration 3022472578) in Englewood Cliffs, NJ, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022472578
- Address
- 930 Sylvan Ave, Suite 125, Englewood Cliffs, NJ, United States, 07632
- Owner or operator
- Surgical Fusion Inc. (10084995)
- Roles
- Complaint file establishment
- First device listed
- April 25, 2022
- Registered through
- 2026
- Brand names listed
- Drill PI-S-A1.6, Drill PI-S-A2.3, Drill PI-S-A3, Guide S-PI / W5, Handpiece Front Cover, SF Push-in Anchor 1.6, SF Push-in Anchor 2.3, SF Push-in Anchor 3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Complaint file establishment | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| April 1, 2024 | K240288 | SF Push- in Anchor | MAI | Substantially Equivalent | Surgical Fusion Technologies GmbH | accessdata.fda.gov |
| January 19, 2018 | K171228 | Fiji Anchor | MAI | Substantially Equivalent | Sportwelding GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Pin, Fixation, Smooth
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Screw, Fixation, Bone
Updated April 1, 2024. 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.