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

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

21 CFR 888.3630 / Orthopedic
FDA source (opens on fda.gov)

QPQ is the FDA product code for Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed, a class II device type, regulated under 21 CFR 888.3630. FDA's definition for this code reads: "A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QPQ
Device name
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
FDA definition
A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
Regulation
21 CFR 888.3630
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QPQ

By decision year
1 clearance under product code QPQ with a decision year between 2021 and 2021, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QPQ by decision year
YearClearances
20211

Applicants with the most clearances

Product code QPQ
Applicants holding the most 510(k) clearances under product code QPQ
ApplicantClearances
Ortho-Space Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code