510(k) clearances

implantcast Packaging System Update

Implantcast GmbH · Orthopedic

K260037Substantially EquivalentTraditionalLZO
Open FDA's page for this record
Third party flag
N
City
Buxtehude
Advisory committee description
Orthopedic
Address 1
Lüneburger Schanze 26
Statement or summary
Summary
Product code
LZO
Zip code
21614
Applicant
Implantcast GmbH
Decision date
2026-03-30
Decision code
SESE
Country code
DE
Device name
implantcast Packaging System Update
Advisory committee
OR
Contact
Juliane Höppner
K number
K260037
Date received
2026-01-06
Review advisory committee
OR
Postal code
21614
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
3042508254, 1835251, 3016778562, 3012523063, 3006536454, 3013055499, 3021008900, 3010576282, 3005360851, 3016438694, 3008668801, 3004638532, 9681465, 3014763043, 1450662, 3026776, 3014273644, 2030624, 3000264985, 3010057495, 1226188, 3006801265, 3003387384, 3014315560, 3005333358, 3036773273, 3014252644, 3007334927, 9681642, 3008868758, 3005751028, 3016438761, 1061927, 3010039400, 3010314800, 3003639920, 2134285, 3003791208, 3006356043, 2249615 +238 more
FEI number
3042508254, 3016778562, 3012523063, 3006536454, 3013055499, 3021008900, 3010576282, 3005360851, 3016438694, 3008668801, 3004638532, 3002808293, 3014763043, 1450662, 3014273644, 3000264985, 3010057495, 3006801265, 3003387384, 3014315560, 3005601732, 3005333358, 3036773273, 3014252644, 3007334927, 3008868758, 3005751028, 3016438761, 3010039400, 3010314800, 3002807036, 3003639920, 3003791208, 3002924544, 3006356043, 1832656, 1000132037, 3007051929, 3001278222, 3011015572 +238 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.