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#
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|---|---|---|---|
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| 03700569674250 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-27 |
| 03700569674274 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-27 |
| 00842188130311 | Tools - Screws | Trimed, INC. | 2026-07-22 |
| 06974940307243 | endophix | Suzhou Endophix Co., Ltd. | 2026-06-23 |
| 08800322750001 | AnyPlus® | GS Medical Co., Ltd. | 2026-04-21 |
| 00810135963404 | Impact | NVision Biomedical Technologies, Inc. | 2025-09-24 |
| 05055662971057 | ORTHO SOLUTIONS SUCCESSION AFN SYSTEM | ORTHO SOLUTIONS HOLDINGS LIMITED | 2025-08-15 |
| 08800071006862 | Surgical Instrument | OSTEONIC CO.,Ltd. | 2025-06-24 |
| B56251300MDG000G10 | WishBone Plate & Screw System | Wishbone Medical, Inc. | 2024-01-01 |
| 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 |
| 10855068008607 | Implant Selection Device | CURVAFIX, INC. | 2022-12-05 |
| B56251300SDG000G10 | WishBone Plate & Screw System | Wishbone Medical, Inc. | 2022-07-18 |
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| 08033390085892 | SMR Shoulder system | LIMACORPORATE SPA | 2018-09-21 |
| 10886982066725 | NA | Synthes GmbH | 2017-02-20 |
| 10886982196545 | NA | Synthes GmbH | 2017-02-20 |
| 10886982195852 | NA | Synthes GmbH | 2017-02-20 |
| 10886982195524 | NA | Synthes GmbH | 2017-02-20 |
| 10886982066794 | NA | Synthes GmbH | 2017-02-20 |