Mcconnell Orthopedic Pelvic Caliper Support
FDA 510(k) K871839 · Mcconnell Orthopedic
510(k) numberK871839
Submission
- Device name
- Mcconnell Orthopedic Pelvic Caliper Support
- Applicant
- Mcconnell Orthopedic
Dallas, TX, US - Received
- May 12, 1987
- Decision date
- May 26, 1987
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K910974 | Mcconnell Shoulder BraceIQI · Traditional | 03/21/1991SE |
| K905565 | Lateral Buttress SupportFWZ · Traditional | 02/21/1991SE |
| K905564 | Prep and Operating StandFWZ · Traditional | 02/21/1991SE |
| K885100 | Mcconnell Reamer GuideHTO · Traditional | 01/13/1989SE |
| K871840 | Mcconnell Orthopedic Ankle PositionerFWZ · Traditional | 05/26/1987SE |
| K871824 | Mcconnell Orthopedic Suspension SystemFWZ · Traditional | 05/26/1987SE |
| K871823 | Mcconnell Orthopedic Tibial PositionerFWZ · Traditional | 05/26/1987SE |
| K871822 | Mcconnell Orthopedic U-Hook AssemblyFWZ · Traditional | 05/26/1987SE |
| K871821 | Mcconnell Orthopedic Posterior Body SupportFWZ · Traditional | 05/26/1987SE |
| K871820 | Mcconnell Orthopedic Anterior Torso-Arm SupportFWZ · Traditional | 05/26/1987SE |
Questions and answers
When was Mcconnell Orthopedic Pelvic Caliper Support cleared by the FDA?
Mcconnell Orthopedic Pelvic Caliper Support (K871839) received a 510(k) decision of Substantially Equivalent on May 26, 1987, 14 days after the submission was received.
What is the product code of K871839?
The FDA product code is FWZ – Operating Room Accessories Table Tray, a Class I (low risk) device regulated under 21 CFR 878.4950.