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

Prosthesis, Tendon, Passive

21 CFR 888.3025 / Orthopedic
FDA source (opens on fda.gov)

HXA is the FDA product code for Prosthesis, Tendon, Passive, a class II device type, regulated under 21 CFR 888.3025. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HXA
Device name
Prosthesis, Tendon, Passive
Regulation
21 CFR 888.3025
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
11
Ingested recalls
0

Clearances, product code HXA

By decision year
11 clearances under product code HXA with a decision year between 1978 and 2025, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HXA by decision year
YearClearances
19782
19851
19873
19931
19972
20001
20251

Applicants with the most clearances

Product code HXA
Applicants holding the most 510(k) clearances under product code HXA
ApplicantClearances
Holter-Hausner Intl.6
Askorn Medical1
Avanta Orthopaedics, Inc.1
Medist International1
Phoenix Bioengineering, Inc.1
Technical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code