Data / Medical devices / United States / Rog Sports Medicine, Inc.
Rog Sports Medicine, Inc.: FDA-registered device maker in Orland Park, IL, United States, 5 510(k) clearances
Rog Sports Medicine, Inc. is registered with the FDA (registration 3009227834) in Orland Park, IL, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 15, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009227834
- Address
- 16450 104th Ave, Orland Park, IL, United States, 60467
- Owner or operator
- RoG Sports Medicine, Inc (10037806)
- Roles
- Specification developer
- First device listed
- August 18, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 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 |
|---|---|---|---|---|---|---|
| December 15, 2011 | K113299 | ROG SUTURE ANCHOR | MBI | Substantially Equivalent | Rog Sports Medicine, Inc. | accessdata.fda.gov |
| December 8, 2011 | K112991 | MODIFIED ROG SUTURE ANCHOR | MBI | Substantially Equivalent | Rog Sports Medicine, Inc. | accessdata.fda.gov |
| August 8, 2011 | K111590 | ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR | MBI | Substantially Equivalent | Rog Sports Medicine, Inc. | accessdata.fda.gov |
| May 19, 2011 | K110230 | ROG KNOTLESS SUTURE ANCHOR | MBI | Substantially Equivalent | Rog Sports Medicine, Inc. | accessdata.fda.gov |
| May 18, 2011 | K110229 | ROG SUTURE ANCHOR 5.5MM, 2.9MM | MBI | Substantially Equivalent | Rog Sports Medicine, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Pad, Heating, Powered
- All makers of Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Updated December 15, 2011. 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.