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 |
|---|---|---|---|
| 00810097803749 | 3.0mm GUIDE WIRE 355mm | Osteocentric Technologies, Inc. | 2026-06-02 |
| 00889024707382 | Persona Tensor Sizer Arm – Long | Zimmer, Inc. | 2026-05-29 |
| 00889024707399 | Persona Tensor Sizer Arm – Std | Zimmer, Inc. | 2026-05-29 |
| 00889024707405 | Persona Tensor Sizer Body | Zimmer, Inc. | 2026-05-29 |
| G079INL1160120 | Inlet Bone Fixation System | Intelivation, LLC | 2026-04-17 |
| G079INL1160070 | Inlet Bone Fixation System | Intelivation, LLC | 2026-04-17 |
| 07640332475348 | CURE 2.0 ACP | SpineArt SA | 2025-11-12 |
| 07640375235732 | PERLA ® TL MIS | SpineArt SA | 2025-11-10 |
| G463090799PK0 | Spine Instruments | BOXSPINE HOLDINGS, INC. | 2025-01-16 |
| 00810118210167 | 3.7mm Parallel Pin | Osteocentric Technologies, Inc. | 2023-10-30 |
| 00810118210174 | 4.2mm Parallel Pin | Osteocentric Technologies, Inc. | 2023-10-30 |
| 00810118210181 | 5.5mm Parallel Pin | Osteocentric Technologies, Inc. | 2023-10-30 |
| 07640187461541 | Monoaxial Drill Guide 3.5mm | Bonebridge AG | 2022-12-23 |
| 10855068008577 | Steerable Guide Sleeve, Small Implant | CURVAFIX, INC. | 2022-12-05 |
| 08800068964731 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964809 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964748 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964755 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964762 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964779 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964786 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964793 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 08800068964724 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-21 |
| 10855068008478 | Steerable Guide Sleeve | CURVAFIX, INC. | 2022-06-20 |
| 10855068008461 | Spiked Start Sleeve, Cannulated | CURVAFIX, INC. | 2022-06-20 |
| 10855068008454 | Drill Sleeve | CURVAFIX, INC. | 2022-06-20 |
| 10855068008447 | Soft Tissue Sleeve | CURVAFIX, INC. | 2022-06-20 |
| 07640185340831 | SCARLET AL-T INSTRUMENTATION | SpineArt SA | 2018-12-10 |
| 07640185340107 | SCARLET AL-T INSTRUMENTATION | SpineArt SA | 2018-12-10 |
| 10886982066763 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |