Medical Device Manufacturer · DE , Buxtehude

Implantcast GmbH - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2017
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Implantcast GmbH Orthopedic
19 devices
1-19 of 19
Cleared Apr 24, 2026
EPORE® XO cup system
K252451 · OQI
Orthopedic · 263d
Cleared Mar 12, 2026
implaFit® short stems
K252401 · LZO
Orthopedic · 224d
Cleared Mar 10, 2025
AGILON® XO Shoulder Replacement System
K241944 · KWT
Orthopedic · 251d
Cleared Oct 24, 2024
MUTARS® femoral stem cemented 160 mm and 200 mm
K240391 · LZO
Orthopedic · 259d
Cleared Sep 06, 2024
ACS® LD FB Knee System
K234044 · JWH
Orthopedic · 260d
Cleared Jun 03, 2024
EcoFit® short stem cementless cpTi
K240834 · LZO
Orthopedic · 69d
Cleared Feb 16, 2024
AGILON® XO Shoulder Replacement System
K231657 · KWT
Orthopedic · 254d
Cleared Oct 19, 2023
Actinia® hip stems
K232371 · LZO
Orthopedic · 72d
Cleared Jun 20, 2023
BethaLoc® stem cementless HA
K223103 · LZO
Orthopedic · 263d
Cleared Sep 28, 2022
AGILON XO Shoulder System
K222482 · KWT
Orthopedic · 42d
Cleared Aug 17, 2022
implaFit® hip stems
K210678 · LZO
Orthopedic · 530d
Cleared Feb 03, 2021
EcoFit® Hip System
K203420 · LZO
Orthopedic · 76d
Cleared Jan 08, 2021
ACS LD Uni FB Knee System
K203341 · HSX
Orthopedic · 57d
Cleared Nov 12, 2020
AGILON® XO Shoulder Replacement System
K191433 · HSD
Orthopedic · 533d
Cleared Oct 16, 2020
MUTARS Cemented Femoral Stems
K200045 · MEH
Orthopedic · 282d
Cleared Aug 28, 2019
Implantcast ic-Bipolar Head System
K191569 · KWY
Orthopedic · 76d
Cleared Mar 25, 2019
MUTARS Proximal Femur Replacement System
K181778 · MEH
Orthopedic · 265d
Cleared Jul 20, 2018
EcoFit Vit E Acetabular System
K180263 · LZO
Orthopedic · 171d
Cleared Sep 25, 2017
Ecofit® Hip System
K163577 · LZO
Orthopedic · 279d
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