Basildon-Gardner Spinal Frame
FDA 510(k) K842700 · Downs Surgical , Ltd.
510(k) numberK842700
Submission
- Device name
- Basildon-Gardner Spinal Frame
- 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
- FWZ – Operating Room Accessories Table Tray
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Other 510(k)s with product code FWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960019 | Retractor Arm ClampFWZ · Traditional | Biopsys Medical, Inc. | 02/09/1996SE |
| K945415 | 'Lil Mac Accessory Clamp(Tm)FWZ · Traditional | D.L. Nelson and Assoc., Inc. | 11/22/1994SE |
| K944779 | Carbon Lights Hand Surgery TableFWZ · Traditional | Allen Medical Systems, Inc. | 10/14/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | Andronic Devices, Ltd. | 04/15/1994SE |
| K931037 | Whitmore Vacuum-Lock Spinal Frame (VLSF-100)FWZ · Traditional | Whitmore Ent., Inc. | 07/30/1993SE |
| K926225 | Sponge CounterFWZ · Traditional | American Medical Manufacturer, Inc. | 03/05/1993SE |
| K925035 | Midkiff Geostatic ClampFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 02/18/1993SE |
| K905565 | Lateral Buttress SupportFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K905564 | Prep and Operating StandFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | Orthopedic Systems, Inc. | 01/24/1991SE |
More from Orthopedic Systems, Inc.
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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 Basildon-Gardner Spinal Frame cleared by the FDA?
Basildon-Gardner Spinal Frame (K842700) 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 K842700?
The FDA product code is FWZ – Operating Room Accessories Table Tray, a Class I (low risk) device regulated under 21 CFR 878.4950.