Cedar(Tm) Retractor Ring
FDA 510(k) K873691 · Cedar Surgical, Inc.
510(k) numberK873691
Submission
- Device name
- Cedar(Tm) Retractor Ring
- Applicant
- Cedar Surgical, Inc.
Minnetonka, MN, US - Received
- September 8, 1987
- Decision date
- September 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GZT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp…GZT · Traditional | Thompson Surgical Instruments, Inc. | 05/13/2022SE |
| K202694 | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS…GZT · Traditional | Vycor Medical, Inc. | 01/14/2021SE |
| K202072 | MindsEye Expandable PortGZT · Traditional | Minnetronix Neuro, Inc. | 08/26/2020SE |
| K180610 | Geister retractor for neuro - and spine surgeryGZT · Traditional | Geister Medizin Technik GmbH | 08/29/2018SE |
| K172433 | NICO BrainPathGZT · Special | Nico Corporation | 09/07/2017SE |
| K161680 | MEDICON Spinal Spreading SystemsGZT · Traditional | Medicon EG | 03/24/2017SE |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional | Tedan Surgical Innovations, LLC | 03/20/2017SE |
| K161004 | Self-retaining RetractorGZT · Traditional | Fetzer Medical GmbH & Co. KG | 09/09/2016SE |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional | Nico Corporation | 06/12/2015SE |
| K120691 | Brain PortGZT · Traditional | Nico Corporation | 06/05/2012SE |
More from Nico Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K873692 | Raylor(Tm) Drill StopHBE · Traditional | 12/17/1987SE |
| K872281 | Raylor Fusion FunnelHXR · Traditional | 11/02/1987SE |
| K873690 | Cedar(Tm) Pelvic CushionLWG · Traditional | 10/26/1987SE |
| K864425 | Raylor(Tm) Dissecting HookGDG · Traditional | 12/12/1986SE |
| K864426 | Raylor(Tm) Depth GaugeHTJ · Traditional | 11/26/1986SE |
| K864424 | Raylor(Tm) Protective RetractorGAD · Traditional | 11/26/1986SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | 11/26/1986SE |
| K864423 | Raylor(Tm) Osteotomes · Traditional | 11/24/1986SE |
| K864422 | Raylor(Tm) MalletHWA · Traditional | 11/24/1986SE |
| K863416 | Raylor Mini-ProbeHAO · Traditional | 09/24/1986SE |
Questions and answers
When was Cedar(Tm) Retractor Ring cleared by the FDA?
Cedar(Tm) Retractor Ring (K873691) received a 510(k) decision of Substantially Equivalent on September 28, 1987, 20 days after the submission was received.
What is the product code of K873691?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.