510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K200384Substantially Equivalent

HipXpert 3D Display and Anchoring Application

Surgical Planning Associates, Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200384 is the FDA 510(k) clearance record for HipXpert 3D Display and Anchoring Application, a class II device, cleared for Surgical Planning Associates, Inc. on under FDA product code OSF (Patient Specific Manual Orthopedic Stereotaxic System). FDA's definition for product code OSF reads: "Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy". FDA records list 3 510(k) clearances for Surgical Planning Associates, Inc., from to . As of , FDA records show no recalls naming K200384.

Clearance record

Decision date
Received
(345 days to decision)
Product code
OSF Patient Specific Manual Orthopedic Stereotaxic System
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Surgical Planning Associates, Inc. New England Baptist Hospital, Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OSF

Trailing 12 months

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

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