Data / Medical devices / United States / Sky Surgical
Sky Surgical: FDA-registered device maker in Parkville, MO, United States, 1 510(k) clearance
Sky Surgical is registered with the FDA (registration 3030691054) in Parkville, MO, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030691054
- Address
- 8600 NW 64th Street #203, Parkville, MO, United States, 64152
- Owner or operator
- Sky Surgical (10090370)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 26, 2024
- Registered through
- 2026
- Brand names listed
- SkyOPS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Broach | HTQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | 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 |
|---|---|---|---|---|---|---|
| December 21, 2023 | K233154 | SkyOPS Orthopedic Plate System | HRS | Substantially Equivalent | Sky Surgical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Depth
- All makers of Template
- All makers of Screwdriver
- All makers of Broach
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
Updated December 21, 2023. 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.