Concept Micromill
by Concept, Inc. 510(k)
Active
510(k) K912957
Overview
The Concept Micromill is an orthopedic device. It received FDA 510(k) clearance under product code HRX.
The device was cleared through the traditional 510(k) pathway on October 4, 1991, with the submission received on July 8, 1991. It is manufactured by Concept, Inc. located at 11311 Concept Blvd., Largo, FL 34643.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912957 | Date4 Oct 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Concept, Inc.
Questions
What is the Concept Micromill used for?
The Concept Micromill is an orthopedic device, as stated in its description, indicating its intended use falls within orthopedic applications, though specific clinical indications are not detailed in the provided data.
How was the Concept Micromill cleared for market?
The Concept Micromill received FDA 510(k) clearance through the traditional 510(k) pathway, with the submission received on July 8, 1991, and clearance granted on October 4, 1991, under product code HRX.
Who manufactures the Concept Micromill and where is it located?
The Concept Micromill is manufactured by Concept, Inc., located at 11311 Concept Blvd., Largo, FL 34643, as specified in the device data.