510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111176Substantially Equivalent

Osteomed Low Profile Neuro Fixation System

Osteomed, Addison TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111176 is the FDA 510(k) clearance record for OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM, a class II device, cleared for Osteomed LP on under FDA product code GWO (Plate, Cranioplasty, Preformed, Alterable). FDA records list 73 510(k) clearances for Osteomed LP, from to . As of , FDA records show 2 recalls naming K111176.

Clearance record

Decision date
Received
(110 days to decision)
Product code
GWO Plate, Cranioplasty, Preformed, Alterable
Regulation
21 CFR 882.5320
Device class
Class II
Review panel
Neurology
Applicant
Osteomed LP 3885 Arapaho Rd., Addison TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWO

Trailing 12 months
2 clearances under product code GWO in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260