Electronic Depth Gauge
The Electronic Depth Gauge (product code OOL) is a Class 2 orthopedic device regulated under 21 CFR 888.3030 in the Orthopedic specialty (OR), cleared via 510(k). It is designed to electronically measure the depth of a passageway in bone or tissue prior to insertion of screws or other hardware, enabling proper sizing and selection of implants during orthopedic surgical procedures. The device is not an implant itself and is not life-sustaining.
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Basic Information
- Product Code
- OOL
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091992 | EIDOSMED, MODEL EDG4.0 | Dec 09, 2009 | Substantially Equivalent | Eidosmed, LLC |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.