510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111538Substantially Equivalent

Skaffold Cis

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

K111538 is the FDA 510(k) clearance record for SKAFFOLD CIS, cleared for Skeletal Kinetics, LLC on under FDA product code MTJ (Wax, Bone). FDA records list 10 510(k) clearances for Skeletal Kinetics, LLC, from to . As of , FDA records show no recalls naming K111538.

Clearance record

Decision date
Received
(145 days to decision)
Product code
MTJ Wax, Bone
Device class
Unclassified
Review panel
Unknown
Applicant
Skeletal Kinetics, LLC 10201 Bubb Rd., Cupertino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MTJ

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