Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System
FDA 510(k) K001353 · Biomedical Ent., Inc.
510(k) numberK001353
Submission
- Device name
- Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System
- Applicant
- Biomedical Ent., Inc.
San Antonio, TX, US - Received
- April 28, 2000
- Decision date
- March 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System cleared by the FDA?
Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System (K001353) received a 510(k) decision of Substantially Equivalent on March 13, 2001, 319 days after the submission was received.
What is the product code of K001353?
The FDA product code is HBW – Fastener, Plate, Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5360.