Product code HXB
- Device name
- Probe
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- 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 |
|---|---|---|---|
| K960539 | DIAO HAND SURGERY SET | Kinetikos Medical, Inc. | 1996-07-23 |
| K943472 | COHORT AVB RETRACTOR SYSTEM | Cohort Medical Products Group, Inc. | 1994-10-20 |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | Flexmedics | 1991-09-24 |
| K890227 | SURGICAL PROBE | Kinetic Medical Products | 1989-01-27 |
| K873651 | BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 | Arthropedics, Inc. | 1987-11-02 |
| K873652 | HOOK PROBE #TM-1376 | Arthropedics, Inc. | 1987-11-02 |
| K863149 | BOWEN PROBE | Bowen & Company, Inc. | 1986-09-05 |
| K841971 | 2.5MM & 4MM PROBE K841969-LABELING | Stainless Mfg., Inc. | 1984-06-19 |
| K840558 | SHUTT PRECISION PROBES | Concept, Inc. | 1984-04-25 |
| K810294 | LINE CADDY | Instranetics, Inc. | 1981-02-26 |
| K802951 | I.M PROBES | Hogan & Hartson | 1980-12-17 |
| K802479 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1980-10-31 |
| K800729 | PROBE | Stainless Mfg., Inc. | 1980-04-08 |
| K800444 | GOLDEN RETRIEVERS OR SILVER RETRIEVERS | Instrument Makar, Inc. | 1980-03-05 |
| K800274 | ACUFEX PROBES | Acufex Microsurgical, Inc. | 1980-02-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840606191302 | Primus | SPINAL ELEMENTS, INC. | 2026-09-22 |
| 00840606191319 | Primus | SPINAL ELEMENTS, INC. | 2026-09-22 |
| 00850088713558 | PRINCETON | Princeton Medical Group, Inc. | 2026-08-14 |
| B382SD9213821020 | Surgical Direct | Surgical Direct, Inc. | 2026-08-07 |
| B382SD4838920 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD483800190 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| 00840606191876 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191869 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840606191593 | Overwatch PCF | SPINAL ELEMENTS, INC. | 2026-07-31 |
| 00840183532383 | BR Surgical, LLC | BR Surgical, LLC | 2026-07-21 |
| 18257200046706 | FIREBIRD SFS,SPECIAL PRODUCTS | Orthofix US LLC | 2026-07-17 |
| 06974940307830 | endophix | Suzhou Endophix Co., Ltd. | 2026-06-23 |
| 08800322758151 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-04-21 |
| 08800322758168 | Anyplus ll Spinal Fixation System | GS Medical Co., Ltd. | 2026-04-21 |
| 08800017271095 | BENCOX | Corentec Co., Ltd | 2026-04-10 |
| 10888857578708 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578685 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578678 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578661 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578654 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578647 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578630 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578203 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578692 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 10888857578197 | Vulcan™ Spinal System | VB Spine LLC | 2026-02-20 |
| 08809885720018 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| 08809885720001 | Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2025-03-17 |
| B7685451520 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-07-06 |
| 00613994230676 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00887482053188 | Symmetry Surgical | ASPEN SURGICAL PRODUCTS, INC. | 2022-08-25 |