British Spinal Fusion Set
FDA 510(k) K842698 · Downs Surgical , Ltd.
510(k) numberK842698
Submission
- Device name
- British Spinal Fusion Set
- Applicant
- Downs Surgical , Ltd.
Mchenry, IL, US - Received
- July 11, 1984
- Decision date
- September 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZX – Guide, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZX
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|---|---|---|---|
| K914715 | Paralleling GuidesFZX · Traditional | Implant Corp. of America | 02/16/1994SE |
| K871413 | Civco StepperFZX · Traditional | CIVCO Medical Instruments Co., Inc. | 07/14/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | Amedic USA | 07/10/1987SE |
| K862564 | A.C.L. Guide KitFZX · Traditional | Aspen Laboratories, Inc. | 08/18/1986SE |
| K854262 | Meadox Surgimed Breast Localization Wire Set/OnlyFZX · Traditional | Meadox Surgimed, Inc. | 12/24/1985SE |
| K852402 | Namic Homer Mammalok Needle/Wire LocalizerFZX · Traditional | North American Instrument Corp. | 07/11/1985SE |
| K841618 | Threading TubeFZX · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K841619 | Drill GuideFZX · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841297 | Techmedica Drill GuideFZX · Traditional | Techmedica, Inc. | 04/25/1984SE |
| K840835 | Straith Drain InserterFZX · Traditional | Surgical Technology Laboratories, Inc. | 04/23/1984SE |
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| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | 10/31/1990SE |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | 10/31/1990SE |
| K903748 | Islam Sternal Puncture Needle, Cat # AF-594-00-VGDM · Traditional | 10/31/1990SE |
| K903747 | Islam Sternal Puncture Needle, Cat # AG-592-00-UGDM · Traditional | 10/31/1990SE |
| K900616 | Shepperd Cutting ForcepsHRX · Traditional | 10/22/1990SE |
| K900615 | Shepperd Nerve Root Retractor W/Suction & FibreHRX · Traditional | 10/22/1990SE |
| K900614 | Shepperd Short Muscle Retractor (GS-501-45-V)HRX · Traditional | 10/22/1990SE |
| K900613 | Shepperd Shelter Tube Complete & DrillHRX · Traditional | 10/22/1990SE |
| K900612 | Shepperd Trephine Set (GS-501-30-V)HRX · Traditional | 10/22/1990SE |
| K900611 | Shepperd Dilatation Tube Set (GS-501-20-H)HRX · Traditional | 10/22/1990SE |
Questions and answers
When was British Spinal Fusion Set cleared by the FDA?
British Spinal Fusion Set (K842698) received a 510(k) decision of Substantially Equivalent on September 12, 1984, 63 days after the submission was received.
What is the product code of K842698?
The FDA product code is FZX – Guide, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.