Gauge, Depth
A depth gauge is a surgical measuring instrument used in orthopedic procedures to determine the depth of a hole drilled in bone, ensuring correct screw or implant length selection. It is classified as an FDA Class 1 device under 21 CFR 888.4300, indicating low risk and general controls only. Product code HTJ falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HTJ
- Device Class
- FDA class 1
- Regulation Number
- 888.4300
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940480 | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | Mar 23, 1994 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Dec 29, 1992 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K873191 | ACROMED INTERBODY DEPTH GAUGES | Sep 09, 1987 | Substantially Equivalent | Buckman Co., Inc. |
| K864426 | RAYLOR(TM) DEPTH GAUGE | Nov 26, 1986 | Substantially Equivalent | Cedar Surgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 372 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 372 registration numbers. Click on an entry to view related FDA registrations.