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

Orthosis, Lumbo-Sacral

21 CFR 890.3490 / Physical Medicine
FDA source (opens on fda.gov)

IPY is the FDA product code for Orthosis, Lumbo-Sacral, a class I device type, regulated under 21 CFR 890.3490. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IPY
Device name
Orthosis, Lumbo-Sacral
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
11
Ingested recalls
1

Clearances, product code IPY

By decision year
11 clearances under product code IPY with a decision year between 1979 and 1983, 1981 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code IPY by decision year
YearClearances
19791
19803
19815
19832

Applicants with the most clearances

Product code IPY
Applicants holding the most 510(k) clearances under product code IPY
ApplicantClearances
Orthomedics3
Surgical Appliance Industries, Inc.2
Buckman Consultants1
Danek Medical, Inc.1
David Hendricks, C.P.O.1
Dow Corning Wright1
Fred Sammons, Inc.1
Vertebrace, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 179 companies shown, in name order