510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K973080Substantially Equivalent

Surgical Vascular Clamp

Biomet Microfixation, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973080 is the FDA 510(k) clearance record for SURGICAL VASCULAR CLAMP, a class II device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K973080.

Clearance record

Decision date
Received
(189 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Walter Lorenz Surgical, Inc. 1520 Tradeport Dr., Jacksonville FL
510(k) summary
Summary
Third party review
No

Clearances, product code DXC

Trailing 12 months
5 clearances under product code DXC in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260
November 20260