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

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

21 CFR 888.3353 / Orthopedic
FDA source (opens on fda.gov)

LZO is the FDA product code for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a class II device type, regulated under 21 CFR 888.3353. As of , FDA records hold 532 510(k) clearances under this code, the most recent dated , and 177 recalls.

Classification record

Product code
LZO
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
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
534
Ingested recalls
177

Clearances, product code LZO

By decision year
534 clearances under product code LZO with a decision year between 1985 and 2026, 1994 the highest year at 36.
Show the numbers
510(k) clearances under FDA product code LZO by decision year
YearClearances
19851
19862
198912
19907
199112
199217
19937
199436
199521
199615
199728
19989
19998
200014
200110
20029
20039
20049
200518
200614
20079
200811
20097
201015
201113
201214
201326
201413
201512
201610
201716
201818
201928
202018
202112
202211
202310
202411
202514
20268

Applicants with the most clearances

Product code LZO
Applicants holding the most 510(k) clearances under product code LZO
ApplicantClearances
Zimmer GmbH56
Medacta International SA37
Corin USA26
Howmedica Osteonics Corp24
Smith & Nephew, Inc.24
Exactech, Inc.21
Howmedica Corp.19
Depuy Orthopaedics Inc.17
Intermedics Orthopedics17
Depuy, Inc.12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 228 companies shown, in name order