510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162864Substantially Equivalent

OsteoVation Impact

Skeletal Kinetics, LLC, Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162864 is the FDA 510(k) clearance record for OsteoVation Impact, a class II device, cleared for Skeletal Kinetics, LLC on under FDA product code GXP (Methyl Methacrylate For Cranioplasty). FDA records list 10 510(k) clearances for Skeletal Kinetics, LLC, from to . As of , FDA records show 7 recalls naming K162864.

Clearance record

Decision date
Received
(92 days to decision)
Product code
GXP Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Applicant
Skeletal Kinetics, LLC 10201 Bubb Rd., Cupertino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXP

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