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Gauge, Depth
FDA product code HTJ · Class 1 · Orthopedic
1,936
Registered devices
3,499
Adverse events
3
Recalls
4
510(k) clearances
Devices with this code
ADJUSTABLE DEPTH STOP — Osteocentric Technologies, Inc.Dyna Locking Trochanteric Nail — CG MedTech Co.,Ltd.Ambler Surgical — AMBLER SURGICAL CORP.ACETABULAR SHELL GAUGE — Biomet Orthopedics, LLCReCap® — Biomet Orthopedics, LLCArthrex® — ARTHREX, INC.Polar — Smith & Nephew, Inc.FuzeFix Large — FUSION ORTHOPEDICS, LLCGeneral Instrument — ORTHOPEDIATRICS CORP.Implant Length Gauge — Osteocentric Technologies, Inc.MOUNTAINEER — DEPUY SPINE, LLCDyna Locking Trochanteric Nail — CG MedTech Co.,Ltd.LOSPA Surgical Instruments — Corentec Co., LtdK-WIRE DEPTH GAUGE — Biomet Orthopedics, LLCHumelock II Cemented Shoulder System — FX SOLUTIONSSumma Orthopaedics System Surgical Instrument — Jeil Medical CorporationCAPTURE™ — Ascension Orthopedics, Inc.Capture High Torque Screw System — Smith & Nephew, Inc.VIPER — DEPUY SPINE, LLCNA — aap Implantate AGFuzeFix Twist Off — FUSION ORTHOPEDICS, LLCDepth gauge — Jeil Medical CorporationM/DN® — Zimmer, Inc.NA — Synthes GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-28 | Zimmer Biomet, Inc. | There is a potential for weak seals of the sterile packaging. |
| 2011-01-27 | Stryker Howmedica Osteonics Corp. | Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in |
| 2009-12-22 | Stryker Howmedica Osteonics Corp. | The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings. |
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