510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250037Unknown

TESSA Spatial Surgery System; INTELLIO Tablet (72205455)

Smith & Nephew, Inc., Andover MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250037 is the FDA 510(k) clearance record for TESSA Spatial Surgery System; INTELLIO Tablet (72205455), a class II device, cleared for Smith & Nephew, Inc. on under FDA product code SIQ (Intra-Articular Orthopedic Stereotaxic Navigation Instrument). FDA's definition for product code SIQ reads: "An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the...". FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming DEN250037.

Clearance record

Decision date
Received
(318 days to decision)
Product code
SIQ Intra-Articular Orthopedic Stereotaxic Navigation Instrument
Regulation
21 CFR 888.4561
Device class
Class II
Review panel
Orthopedic
Applicant
Smith & Nephew, Inc. 150 Minuteman Rd., Andover MA
Third party review
No

Clearances, product code SIQ

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