510(k) clearances

Klassic Knee System - Revision Tibial Baseplate

Total Joint Othopedics, Inc. · Orthopedic

K243991Substantially EquivalentTraditionalJWH
Open FDA's page for this record
Third party flag
N
City
Salt Lake City
Advisory committee description
Orthopedic
Address 1
1567 E. Stratford Ave.
Statement or summary
Summary
Product code
JWH
Zip code
84106
Applicant
Total Joint Othopedics, Inc.
Decision date
2025-03-24
Decision code
SESE
Country code
US
Device name
Klassic Knee System - Revision Tibial Baseplate
Advisory committee
OR
Contact
Bobbi Siddoway
K number
K243991
State
UT
Date received
2024-12-26
Review advisory committee
OR
Postal code
84106
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medical specialty description
Orthopedic
Regulation number
888.3560
Device class
2
Registration number
1422549, 3003916006, 1226544, 3004450489, 3002806603, 3006801265, 3013280419, 3006946276, 3009871135, 3004153240, 3010400367, 3006563559, 3011295718, 3010375065, 3010370880, 2531477, 3036756245, 3034676720, 3010039400, 1219655, 1828288, 1038671, 3005751028, 3009882462, 3005652161, 3015978338, 3016096064, 3007913880, 3010576282, 3013176080, 3008021110, 3007963827, 3010132111, 2030624, 3005551626, 3002808022, 3011461101, 3008110533, 3010363503, 1047843 +282 more
FEI number
3003916006, 3004450489, 3002806603, 3006801265, 3013280419, 1000139987, 3006946276, 1000199976, 3007282753, 1000143502, 3005568854, 3009871135, 3004153240, 3010400367, 3006563559, 3011295718, 3010375065, 3010370880, 3036756245, 3034676720, 3010039400, 3003142829, 1219655, 1828288, 1038671, 1000118610, 3005751028, 3002808402, 3009882462, 3005652161, 3015978338, 3016096064, 3007913880, 3010576282, 3013176080, 3008021110, 3007963827, 3010132111, 3005551626, 3002808022 +282 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.