KSF Posterior Spingal Fixator for Severe Spondylolisthesis
FDA 510(k) K950999 · Buckman Co., Inc.
510(k) numberK950999
Submission
- Device name
- KSF Posterior Spingal Fixator for Severe Spondylolisthesis
- Applicant
- Buckman Co., Inc.
Concord, CA, US - Received
- March 3, 1995
- Decision date
- January 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was KSF Posterior Spingal Fixator for Severe Spondylolisthesis cleared by the FDA?
KSF Posterior Spingal Fixator for Severe Spondylolisthesis (K950999) received a 510(k) decision of Substantially Equivalent on January 25, 1996, 328 days after the submission was received.
What is the product code of K950999?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.