510(k) K223103
- Device
- BethaLoc® stem cementless HA
- Applicant
- Implantcast GmbH
- 510(k) number
- K223103
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-20
- Date received
- 2022-09-30
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Juliane Hoppner
- Address
- Lüneburger Schanze 26 Buxtehude DE 21614 21614
FDA Registration Numbers
- 3002807408
- 9616680
- 1218882
- 1000577893
- 9615800
- 3020967480
- 3006128100
- 8010379
- 3000258338
- 3004493876
- 3007200272
- 2528981
- 3022142628
- 9610612
- 3014763043
- 2244478
- 3012916784
- 3026776
- 1835444
- 1423662
- 3012119238
- 3021008900
- 3013194153
- 3004986960
- 3015167917
- 3007740680
- 3010846112
- 3002807314
- 3016778562
- 1226188
- 9615674
- 3010287737
- 3005323511
- 3033509898
- 3016438761
- 3008110533
- 3009813841
- 3009760038
- 3010047454
- 3008668801
- 3005562917
- 2648920
- 1047843
- 3015398319
- 3002907620
- 3010206549
- 1530390
- 2032521
- 3000196378
- 3026771806
- 3009973505
- 1043653
- 3004371426
- 1221053
- 2249697
- 1000294921
- 3008868758
- 3014315560
- 1644408
- 2245304
- 3001284227
- 3006395932
- 3018052045
- 3002807090
- 3010097171
- 1018470
- 3008262872
- 3009756327
- 3010363503
- 3010531069
- 3008556682
- 1064858
- 9616671
- 8043792
- 1057425
- 1818910
- 1000547811
- 1836357
- 3000264985
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048844236205 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236076 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236090 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236106 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236113 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236137 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236144 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236151 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236175 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236182 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236199 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844358402 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236212 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844236236 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844239442 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844239459 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844239473 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844239480 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844358372 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844358389 | BethaLoc® | implantcast GmbH | 2023-06-27 |
| 04048844358396 | BethaLoc® | implantcast GmbH | 2023-06-27 |
Other 510(k) Records For Product Code LZO
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. | 2026-04-27 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026-01-15 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 |
| K243043 | Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 |
| K243029 | Origin TT Stem | Signature Orthopaedics Pty, Ltd. | 2025-03-11 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | 2025-03-06 |