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

Spatula, Orthopedic

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

HXR is the FDA product code for Spatula, Orthopedic, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HXR
Device name
Spatula, Orthopedic
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code HXR

By decision year
4 clearances under product code HXR with a decision year between 1985 and 1999, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HXR by decision year
YearClearances
19851
19872
19991

Applicants with the most clearances

Product code HXR
Applicants holding the most 510(k) clearances under product code HXR
ApplicantClearances
Arthropedics, Inc.1
Cedar Surgical, Inc.1
Holter-Hausner Intl.1
Micro Medical Devices, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 52 companies shown, in name order