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

Halter, Head, Traction

21 CFR 888.5890 / Orthopedic
FDA source (opens on fda.gov)

HSS is the FDA product code for Halter, Head, Traction, a class I device type, regulated under 21 CFR 888.5890. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HSS
Device name
Halter, Head, Traction
Regulation
21 CFR 888.5890
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code HSS

By decision year
3 clearances under product code HSS with a decision year between 1976 and 1977, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HSS by decision year
YearClearances
19761
19772

Applicants with the most clearances

Product code HSS
Applicants holding the most 510(k) clearances under product code HSS
ApplicantClearances
Fraser Sweatman, Inc.1
Orthopedic Equipment Co., Inc.1
Mizuho Orthopedic Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order