510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001353Substantially Equivalent

Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System

Biomedical Ent., Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001353 is the FDA 510(k) clearance record for MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM, a class II device, cleared for Biomedical Ent., Inc. on under FDA product code HBW (Fastener, Plate, Cranioplasty). FDA records list 13 510(k) clearances for Biomedical Ent., Inc., from to . As of , FDA records show no recalls naming K001353.

Clearance record

Decision date
Received
(319 days to decision)
Product code
HBW Fastener, Plate, Cranioplasty
Regulation
21 CFR 882.5360
Device class
Class II
Review panel
Neurology
Applicant
Biomedical Ent., Inc. 14785 Omicron Dr., Suite 205, San Antonio TX
510(k) summary
Summary
Third party review
No

Clearances, product code HBW

Trailing 12 months

FDA records hold no clearances under product code HBW in the trailing twelve months.

FDA records show no clearances under product code HBW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260