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

Sacroiliac Screw Placement Guide

21 CFR 888.3040 / Orthopedic
FDA source (opens on fda.gov)

QSR is the FDA product code for Sacroiliac Screw Placement Guide, a class II device type, regulated under 21 CFR 888.3040. FDA's definition for this code reads: "A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QSR
Device name
Sacroiliac Screw Placement Guide
FDA definition
A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans.
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QSR

By decision year
1 clearance under product code QSR with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QSR by decision year
YearClearances
20221

Applicants with the most clearances

Product code QSR
Applicants holding the most 510(k) clearances under product code QSR
ApplicantClearances
Medacta International SA1

Companies listing this code with FDA

Companies whose registered establishments list this code