Data / Medical devices / United States / Integrity Orthopaedics, Inc.
Integrity Orthopaedics, Inc.: FDA-registered device maker in Maple Plain, MN, United States, 1 510(k) clearance
Integrity Orthopaedics, Inc. is registered with the FDA (registration 3026368553) in Maple Plain, MN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026368553
- Address
- 5565 Pioneer Creek Drive, Maple Plain, MN, United States, 55359
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Manufacturer
- First device listed
- October 5, 2006
- Registered through
- 2026
- Brand names listed
- 1.5 MM TENDON DRILL PIN, 1.5mm Guidewire, 12", 72202189, 10MM DILATOR, 11MM DILATOR, 12MM DILATOR, 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE, 2.7 MM DILATOR, 3.5 MM DILATOR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | 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 |
|---|---|---|---|---|---|---|
| January 26, 2023 | K222589 | Flexible Suturing System with Anchors (FSSA) | MBI | Substantially Equivalent | Integrity Orthopaedics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Orthopedic Manual Surgical Instrument
Updated January 26, 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.