IntelliSense Drill Technology 1.0
by Mcginley Orthopaedic Innovations, Inc 61 variants
IntelliSense Drill Technology 1.0 (MCG100-10S) is a Class I device made by Mcginley Orthopaedic Innovations, Inc, cleared under FDA 510(k) K143191 on 20 Feb 2015 and listed in FDA GUDID since 5 Dec 2022 (UDI-DI B666MCG100100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB666MCG100100 | Date5 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143191 | Date20 Feb 2015 | StatusActive |
Official records
- FDA 510(k) database K143191
Across registries
- FDA 510(k) K143191 decided 20 Feb 2015 Active
- FDA GUDID UDI-DI B666MCG100100 listed 5 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K143191
- Listed FDA GUDID B666MCG100100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IntelliSense Drill Technology
- Generic name
- Fluted surgical drill bit, single-use
- Model / Ref / Catalog
- 1.0, MCG100-10S
- Primary DI / UDI-DI
- B666MCG100100
- 510(k) Number
- FDA product code
- GFG
- GMDN term
- Fluted surgical drill bit, single-use
- Device class
- Class I
- Regulation number
- 878.4820
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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