Blades for Spinal Laminectomy Retractor
FDA 510(k) K910621 · International Hospital Supply Co.
510(k) numberK910621
Submission
- Device name
- Blades for Spinal Laminectomy Retractor
- Applicant
- International Hospital Supply Co.
Tarzana, CA, US - Received
- February 12, 1991
- Decision date
- April 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp…GZT · Traditional | Thompson Surgical Instruments, Inc. | 05/13/2022SE |
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| K172433 | NICO BrainPathGZT · Special | Nico Corporation | 09/07/2017SE |
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| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional | Tedan Surgical Innovations, LLC | 03/20/2017SE |
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| 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 |
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Questions and answers
When was Blades for Spinal Laminectomy Retractor cleared by the FDA?
Blades for Spinal Laminectomy Retractor (K910621) received a 510(k) decision of Substantially Equivalent on April 1, 1991, 48 days after the submission was received.
What is the product code of K910621?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.