Oec/Rezaian Spinal Fixator
FDA 510(k) K841189 · Orthopedic Equipment Co., Inc.
510(k) numberK841189
Submission
- Device name
- Oec/Rezaian Spinal Fixator
- Applicant
- Orthopedic Equipment Co., Inc.
Walker, MI, US - Received
- March 20, 1984
- Decision date
- May 16, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
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| K834035 | Universal Self-Aligning Acetabular ComJDI · Traditional | 06/19/1984SE |
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| K790209 | Filter System, Altner DisposableGAZ · Traditional | 02/26/1979SE |
| K781451 | Flat WrenchHXS · Traditional | 09/27/1978SE |
| K781450 | DriversGFC · Traditional | 09/27/1978SE |
| K781449 | Harrington Spinal ElevatorGEG · Traditional | 09/27/1978SE |
| K781448 | Harrington Hook ClampGEN · Traditional | 09/27/1978SE |
| K781447 | Threaded Rod ClampGEN · Traditional | 09/27/1978SE |
Questions and answers
When was Oec/Rezaian Spinal Fixator cleared by the FDA?
Oec/Rezaian Spinal Fixator (K841189) received a 510(k) decision of Substantially Equivalent on May 16, 1984, 57 days after the submission was received.
What is the product code of K841189?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.