Burr Hole Covers, Craniomaxillofacial Plates
FDA 510(k) K983885 · Howmedica, Inc.
510(k) numberK983885
Submission
- Device name
- Burr Hole Covers, Craniomaxillofacial Plates
- Applicant
- Howmedica, Inc.
Rutherford, NJ, US - Received
- November 2, 1998
- Decision date
- January 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Burr Hole Covers, Craniomaxillofacial Plates cleared by the FDA?
Burr Hole Covers, Craniomaxillofacial Plates (K983885) received a 510(k) decision of Substantially Equivalent on January 29, 1999, 88 days after the submission was received.
What is the product code of K983885?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.