510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910555Substantially Equivalent

Tutoplast Dura

Pfrimmer-Viggo GmbH & Co., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910555 is the FDA 510(k) clearance record for TUTOPLAST DURA, a class II device, cleared for Pfrimmer-Viggo GmbH & Co. on under FDA product code LEM (Human Lyophilized Dura Mater). FDA's definition for product code LEM reads: "Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d). Subject to donor eligibility, good tissue practice, registration...". FDA records list one 510(k) clearance for Pfrimmer-Viggo GmbH & Co. As of , FDA records show no recalls naming K910555.

Clearance record

Decision date
Received
(438 days to decision)
Product code
LEM Human Lyophilized Dura Mater
Regulation
21 CFR 882.5975
Device class
Class II
Review panel
Neurology
Applicant
Pfrimmer-Viggo GmbH & Co. C/O Kleinfeld, Kaplan & Becker, Washington DC
Third party review
No

Clearances, product code LEM

Trailing 12 months

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

FDA records show no clearances under product code LEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LEM, 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