Osstaple, Maxillofacial
FDA 510(k) K023486 · Biomedical Enterprises, Inc.
510(k) numberK023486
Submission
- Device name
- Osstaple, Maxillofacial
- Applicant
- Biomedical Enterprises, Inc.
San Antonio, TX, US - Received
- October 17, 2002
- Decision date
- October 31, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K023488 | Osstaple, CraniofacialJEY · Special | 10/31/2002SE |
Questions and answers
When was Osstaple, Maxillofacial cleared by the FDA?
Osstaple, Maxillofacial (K023486) received a 510(k) decision of Substantially Equivalent on October 31, 2002, 14 days after the submission was received.
What is the product code of K023486?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.