510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922870Substantially Equivalent

Three Spike Cup

Osteo Technology, Inc., Timonium MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922870 is the FDA 510(k) clearance record for THREE SPIKE CUP, a class I device, cleared for Osteo Technology, Inc. on under FDA product code GRF (Antiserum, Cf, Rubeola). FDA records list 18 510(k) clearances for Osteo Technology, Inc., from to . As of , FDA records show no recalls naming K922870.

Clearance record

Decision date
Received
(308 days to decision)
Product code
GRF Antiserum, Cf, Rubeola
Regulation
21 CFR 866.3520
Device class
Class I
Review panel
Microbiology
Applicant
Osteo Technology, Inc. 10 W. Aylesbury Rd., Timonium MD
510(k) summary
Statement
Third party review
No

Clearances, product code GRF

Trailing 12 months

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

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