510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121304Substantially Equivalent

Osteomed Cranial Distraction System

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

K121304 is the FDA 510(k) clearance record for OSTEOMED CRANIAL DISTRACTION SYSTEM, a class II device, cleared for Osteomed on under FDA product code PBJ (Cranial Distraction System). FDA's definition for product code PBJ reads: "A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments". FDA records list 73 510(k) clearances for Osteomed, from to . As of , FDA records show no recalls naming K121304.

Clearance record

Decision date
Received
(113 days to decision)
Product code
PBJ Cranial Distraction System
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Osteomed 3885 Arapaho Rd., Addison TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBJ

Trailing 12 months

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

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