Data / Medical devices / United States / Iconn Orthopedics, LLC
Iconn Orthopedics, LLC: FDA-registered device maker in Birmingham, AL, United States, 4 510(k) clearances
Iconn Orthopedics, LLC is registered with the FDA (registration 3010887276) in Birmingham, AL, United States. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010887276
- Address
- 400 Union Hill Dr Ste 150, Birmingham, AL, United States, 35209
- Owner or operator
- ICONN Orthopedics, LLC (10046864)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 11, 2018
- Registered through
- 2026
- Brand names listed
- ICONN Answer 4.75/5.5MM Suture Anchor Awl (247502), ICONN Answer II 4.75/5.5MM Suture Anchor Driver (247506), ICONN Answer II Awl/Tap (247509), ICONN Answer II Suture Anchor, ICONN Campbell Interference Screw, ICONN Instrument Tray (200001/2), ICONN Revolution Knotless Suture Anchor, ICONN Revolution Knotless Suture Anchor Awl (351004) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brace, Drill | HXY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, 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 7, 2018 | K180670 | ICONN Campbell Interference Screw | HWC | Substantially Equivalent | Iconn Orthopedics, LLC | accessdata.fda.gov |
| October 19, 2018 | K182264 | ICONN Revolution Knotless Suture Anchor | MBI | Substantially Equivalent | Iconn Orthopedics, LLC | accessdata.fda.gov |
| August 9, 2018 | K181680 | ICONN Answer II Suture Anchor | MBI | Substantially Equivalent | Iconn Orthopedics, LLC | accessdata.fda.gov |
| November 29, 2017 | K172491 | ICONN Square 2.5MM Suture Anchor | MBI | Substantially Equivalent | Iconn Orthopedics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Screwdriver
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Screw, Fixation, Bone
- All makers of Brace, Drill
Updated December 7, 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.