510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K163338Substantially Equivalent

OMNIBotics Knee System

Omnllife Science, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163338 is the FDA 510(k) clearance record for OMNIBotics Knee System, a class II device, cleared for Omnllife Science, Inc. on under FDA product code OLO (Orthopedic Stereotaxic Instrument). FDA's definition for product code OLO reads: "Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW". FDA records list one 510(k) clearance for Omnllife Science, Inc. As of , FDA records show no recalls naming K163338.

Clearance record

Decision date
Received
(277 days to decision)
Product code
OLO Orthopedic Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Omnllife Science, Inc. 480 Paramount Dr., Raynham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLO

Trailing 12 months
46 clearances under product code OLO in the twelve months to October 2026, February 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code OLO, trailing twelve months
MonthClearances
November 20252
December 20254
January 20262
February 202610
March 20267
April 20262
May 20265
June 20265
July 20266
August 20261
September 20261
October 20261