510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960685Substantially Equivalent

Orthodoc Preoperative Planner Model 500

Integrated Surgical Systems, Inc., Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960685 is the FDA 510(k) clearance record for ORTHODOC PREOPERATIVE PLANNER MODEL 500, a class I device, cleared for Integrated Surgical Systems, Inc. on under FDA product code HWT (Template). FDA records list 4 510(k) clearances for Integrated Surgical Systems, Inc., from to . As of , FDA records show no recalls naming K960685.

Clearance record

Decision date
Received
(332 days to decision)
Product code
HWT Template
Regulation
21 CFR 888.4800
Device class
Class I
Review panel
Orthopedic
Applicant
Integrated Surgical Systems, Inc. 829 W. Stadium Ln., Sacramento CA
510(k) summary
Summary
Third party review
No

Clearances, product code HWT

Trailing 12 months

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

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