Product code HTJ
- Device name
- Gauge, Depth
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4300
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940480 | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | Acufex Microsurgical, Inc. | 1994-03-23 |
| K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Acufex Microsurgical, Inc. | 1992-12-29 |
| K873191 | ACROMED INTERBODY DEPTH GAUGES | Buckman Co., Inc. | 1987-09-09 |
| K864426 | RAYLOR(TM) DEPTH GAUGE | Cedar Surgical, Inc. | 1986-11-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800071006862 | Surgical Instrument | OSTEONIC CO.,Ltd. | 2025-06-24 |
| 07708604560472 | SAMPEDRO | INDUSTRIAS MEDICAS SAMPEDRO S A S | 2023-01-18 |
| 08055727374561 | DEPTH GAUGE 9 mm | HPF SRL | 2022-12-09 |
| 08055727374578 | DEPTH GAUGE 9 mm | HPF SRL | 2022-12-09 |
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| 08806390856249 | VERUM System Surgical Instrument | Jeil Medical Corporation | 2018-09-07 |
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| 08806390865289 | Summa Orthopaedics System Surgical Instrument | Jeil Medical Corporation | 2018-09-07 |