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

Rod, Fixation, Intramedullary And Accessories

21 CFR 888.3020 / Orthopedic
FDA source (opens on fda.gov)

HSB is the FDA product code for Rod, Fixation, Intramedullary And Accessories, a class II device type, regulated under 21 CFR 888.3020. As of , FDA records hold 530 510(k) clearances under this code, the most recent dated , and 690 recalls.

Classification record

Product code
HSB
Device name
Rod, Fixation, Intramedullary And Accessories
Regulation
21 CFR 888.3020
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
531
Ingested recalls
690

Clearances, product code HSB

By decision year
531 clearances under product code HSB with a decision year between 1977 and 2026, 2017 the highest year at 23.
Show the numbers
510(k) clearances under FDA product code HSB by decision year
YearClearances
19771
19791
19801
19816
19822
19831
19854
19865
19876
19884
19893
19902
19914
19929
19936
199411
199510
199613
199716
199816
199914
20008
200120
200221
200314
200417
200513
20064
20078
200811
200918
201014
201116
201217
201318
201419
201522
20168
201723
201817
201913
202017
202110
202212
202311
202413
202515
202617

Applicants with the most clearances

Product code HSB
Applicants holding the most 510(k) clearances under product code HSB
ApplicantClearances
Howmedica Osteonics Corp39
Zimmer GmbH31
Synthes (USA) Products LLC29
Howmedica Corp.26
NuVasive Specialized Orthopedics, Inc.17
Advanced Orthopaedic Solutions, Inc.15
Orthofix SRL14
Stryker Corp.12
Smith & Nephew, Inc.11
Ellipse Technologies, Inc.10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 261 companies shown, in name order