Probe
FDA product code HXB · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
15510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960539 | Diao Hand Surgery SetHXB · Traditional | Kinetikos Medical, Inc. | 07/23/1996SE |
| K943472 | Cohort Avb Retractor SystemHXB · Traditional | Cohort Medical Products Group, Inc. | 10/20/1994SE |
| K912843 | Flexmedics Retract Orth Probe, Pettine Bone ProbeHXB · Traditional | Flexmedics | 09/24/1991SE |
| K890227 | Surgical ProbeHXB · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K873652 | Hook Probe #TM-1376HXB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873651 | Blunt Measuring Probe W/2MM Gradations #TM-1375HXB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K863149 | Bowen ProbeHXB · Traditional | Bowen & Company, Inc. | 09/05/1986SE |
| K841971 | 2.5MM & 4MM Probe K841969-LABELINGHXB · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K840558 | Shutt Precision ProbesHXB · Traditional | Concept, Inc. | 04/25/1984SE |
| K810294 | Line CaddyHXB · Traditional | Instranetics, Inc. | 02/26/1981SE |
| K802951 | I.M ProbesHXB · Traditional | Hogan & Hartson | 12/17/1980SE |
| K802479 | Surgical Knives & ProbesHXB · Traditional | Eder Instrument Co, Inc. | 10/31/1980SE |
| K800729 | ProbeHXB · Traditional | Stainless Mfg., Inc. | 04/08/1980SE |
| K800444 | Golden Retrievers or Silver RetrieversHXB · Traditional | Instrument Makar, Inc. | 03/05/1980SE |
| K800274 | Acufex ProbesHXB · Traditional | Acufex Microsurgical, Inc. | 02/19/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0953-2025 Class II | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-0851-2015 Class II | NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5…During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate… | Zimmer Trabecular Metal Technology, Inc. | 12/02/2014Terminated |
| Z-0624-2014 Class II | PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. | SpineFrontier, Inc. | 09/11/2013Terminated |