Data / Medical devices / United States / Implant Resource, Inc.
Implant Resource, Inc.: FDA-registered device maker in Eagan, MN, United States, 1 510(k) clearance
Implant Resource, Inc. is registered with the FDA (registration 2184171) in Eagan, MN, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 11, 2000. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2184171
- FEI number
- 1000139815
- Address
- 917 Lone Oak Rd, Suite 1000, Eagan, MN, United States, 55121
- Owner or operator
- IMPLANT RESOURCE, INC dba MEDICAL PRODUCTS RESOURCE (9010087)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 17, 2003
- Registered through
- 2026
- Brand names listed
- MPR Pins, MPR TKA Systems, MPR-11200-1000, MPR012045, MPR389.265, SURGIPRESS TOURNIQUET
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | 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 |
|---|---|---|---|---|---|---|
| October 11, 2000 | K002125 | PINS AND WIRES | HTY | Substantially Equivalent | Implant Resource, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 21, 2021 | 88585 | Class II | Ongoing | MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource www.m-p-r.com MPR-1120-1000 (01)00840001405868 | Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected | accessdata.fda.gov |
Compare with other makers
- All makers of Positioner, Socket
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Pin, Fixation, Smooth
- All makers of Mallet
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Tourniquet, Pneumatic
Updated October 11, 2000. 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.