Isola Twister Connector
FDA 510(k) K965046 · Acromed Corp.
510(k) numberK965046
Submission
- Device name
- Isola Twister Connector
- Applicant
- Acromed Corp.
Cleveland, OH, US - Received
- December 18, 1996
- Decision date
- March 14, 1997
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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| K971248 | Kaneda SR Anterior Spinal SystemKWQ · Traditional | 06/11/1997SN |
| K970955 | Acromed Anterior Cervical Stabilization SystemKWQ · Traditional | 06/11/1997SN |
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Questions and answers
When was Isola Twister Connector cleared by the FDA?
Isola Twister Connector (K965046) received a 510(k) decision of Substantially Equivalent for Some Indications on March 14, 1997, 86 days after the submission was received.
What is the product code of K965046?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.