Product code FZX
- Device name
- Guide, Surgical, Instrument
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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 |
|---|---|---|---|
| K914715 | PARALLELING GUIDES | Implant Corp. of America | 1994-02-16 |
| K871413 | CIVCO STEPPER | CIVCO Medical Instruments Co., Inc. | 1987-07-14 |
| K871503 | BIOPSY NEEDLE GUIDE KIT, STERILE | Amedic USA | 1987-07-10 |
| K862564 | A.C.L. GUIDE KIT | Aspen Laboratories, Inc. | 1986-08-18 |
| K854262 | MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY | Meadox Surgimed, Inc. | 1985-12-24 |
| K852402 | NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER | North American Instrument Corp. | 1985-07-11 |
| K842698 | BRITISH SPINAL FUSION SET | Downs Surgical , Ltd. | 1984-09-12 |
| K841618 | THREADING TUBE | Plastafil, Inc. | 1984-08-27 |
| K841619 | DRILL GUIDE | Plastafil, Inc. | 1984-07-11 |
| K841297 | TECHMEDICA DRILL GUIDE | Techmedica, Inc. | 1984-04-25 |
| K840835 | STRAITH DRAIN INSERTER | Surgical Technology Laboratories, Inc. | 1984-04-23 |
| K834350 | ACUFEX DREZ COMMUNICATING DRILL GUIDE | Acufex Microsurgical, Inc. | 1984-03-19 |
| K830720 | GRAF MENISCAL SUTURE SET | Acufex Microsurgical, Inc. | 1983-06-16 |
| K821618 | DISPOSABLE NEEDLE HOLDERS | Medcare Products | 1982-06-21 |
| K810888 | BOUNDARY TUBING HOLDERS | The Buckeye Cellulose Corp. | 1981-04-23 |
| K810788 | SURGICAL TUBE HOLDER | The Urology Group | 1981-04-17 |
| K802093 | GABBAY-FRATER SUTURE GUIDE | Howmedica Corp. | 1980-09-26 |
| K792468 | FEEDING TUBE PLACEMENT STYLET | Biosearch Medical Products, Inc. | 1979-12-27 |
| K790872 | ENTERIC TUBE GUIDE | Biosearch Medical Products, Inc. | 1979-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886982350640 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350633 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982357182 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982351692 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982351142 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982351135 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982351128 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982351111 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982351104 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982351098 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350688 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350671 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350664 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350657 | VOLT | Synthes GmbH | 2026-09-25 |
| 00190776432164 | Millennium | Avalign Technologies, Inc. | 2026-09-22 |
| 00810111228527 | Drill Guide | Treace Medical Concepts, Inc. | 2026-09-21 |
| 00840124519220 | IntraLock | FUSION ORTHOPEDICS, LLC | 2025-05-14 |
| 00840124507500 | IntraLock | FUSION ORTHOPEDICS, LLC | 2023-05-12 |
| 00860009784901 | Guide | Mirrorme3d, LLC | 2023-02-16 |
| 00885556865330 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-02-01 |
| 00885556865354 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-02-01 |
| 00885556865750 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-02-01 |
| 00885556865767 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-02-01 |
| 00885556865323 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-02-01 |
| 00885556865422 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-01-19 |
| 00885556865446 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-01-19 |
| 00885556865286 | Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 2023-01-19 |
| 00196852441754 | Guide | Mirrorme3d, LLC | 2022-10-03 |
| 00840096403978 | Viant Medical, LLC | VIANT MEDICAL | 2020-05-13 |
| 00840096401264 | Viant Medical, LLC | VIANT MEDICAL | 2020-05-13 |