510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192629Substantially Equivalent

Spinalytics

Optima Health Solutions International Corp., Vancouver, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192629 is the FDA 510(k) clearance record for Spinalytics, cleared for Optima Health Solutions International Corp. on under FDA product code LXM (Manipulator, Plunger-Like Joint). FDA records list 3 510(k) clearances for Optima Health Solutions International Corp., from to . As of , FDA records show no recalls naming K192629.

Clearance record

Decision date
Received
(89 days to decision)
Product code
LXM Manipulator, Plunger-Like Joint
Device class
Unclassified
Review panel
Unknown
Applicant
Optima Health Solutions International Corp. Unit 303 - 828 W 8th Ave., Vancouver, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXM

Trailing 12 months

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

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