510(k) clearances

M-Vizion Femoral Revision System Extension

Medacta International S.A. · Orthopedic

K260173Substantially EquivalentTraditionalLZO
Open FDA's page for this record
Third party flag
N
City
Castel San Pietro
Advisory committee description
Orthopedic
Address 1
Strada Regina
Statement or summary
Summary
Product code
LZO
Zip code
6874
Applicant
Medacta International S.A.
Decision date
2026-09-17
Decision code
SESE
Country code
CH
Device name
M-Vizion Femoral Revision System Extension
Advisory committee
OR
Contact
Stefano Baj
K number
K260173
Date received
2026-01-21
Review advisory committee
OR
Postal code
6874
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Medical specialty description
Orthopedic
Regulation number
888.3353
Device class
2
Registration number
3016438761, 9616671, 2249615, 3012392319, 1835251, 3014273644, 3000264985, 3013176080, 3007311878, 3042508254, 1526711, 3020282716, 1000547811, 1835831, 3010097171, 3020155054, 1834331, 3010220595, 3010047454, 3014252644, 3026771806, 3002806470, 3005751028, 3009475821, 3010057495, 3005323511, 3010468876, 3007391088, 3010386387, 3012523063, 3015516266, 3004635447, 3004748528, 3017397663, 3008668801, 3009241418, 3003791208, 9616680, 1833920, 1643817 +238 more
FEI number
1000118610, 3016438761, 3002806315, 3012392319, 3014273644, 3013176080, 3000264985, 3007311878, 3042508254, 1526711, 3020282716, 1000547811, 3003714383, 3010097171, 3020155054, 3010220595, 3010047454, 3014252644, 3002807172, 3026771806, 3002806470, 3005751028, 3009475821, 3010057495, 3005323511, 3017397663, 3007391088, 3010386387, 3012523063, 3015516266, 3004635447, 3004748528, 1000132037, 3008668801, 3009241418, 3003791208, 3002459190, 1643817, 3002807113, 3008110533 +238 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.