Luhr Mandibular/Small Fixation Implants
FDA 510(k) K950595 · Howmedica Corp.
510(k) numberK950595
Submission
- Device name
- Luhr Mandibular/Small Fixation Implants
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- February 9, 1995
- Decision date
- July 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Luhr Mandibular/Small Fixation Implants cleared by the FDA?
Luhr Mandibular/Small Fixation Implants (K950595) received a 510(k) decision of Substantially Equivalent on July 12, 1995, 153 days after the submission was received.
What is the product code of K950595?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.