510(k) K022120
- Device
- MPF ACETABULAR CUP GENERATION 2
- Applicant
- PLUS ORTHOPEDICS
- 510(k) number
- K022120
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-24
- Date received
- 2002-07-01
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HARTMUT LOCH
- Address
- 6055 Lusk Blvd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3014315560
- 3015516266
- 3008812251
- 3020282716
- 2249697
- 3036756245
- 3008021110
- 3003541440
- 1834379
- 3008793310
- 3034676720
- 3007391088
- 1835444
- 3004142400
- 9613350
- 3010120135
- 1722511
- 3009241418
- 3007740680
- 3000236920
- 9610612
- 3012439458
- 3009959868
- 3012319330
- 1827096
- 3008556682
- 3012916784
- 3008572101
- 3009813841
- 1720929
- 3014763043
- 1643817
- 3002807295
- 9681465
- 3009106092
- 3000196378
- 1000200989
- 3010536692
- 9616680
- 3009998573
- 3002806470
- 9615800
- 3009871135
- 3007353762
- 3010375065
- 3013302242
- 1000547811
- 3021386586
- 3014170143
- 1064858
- 3010155661
- 1530390
- 3003477135
- 3010173425
- 9613369
- 3010041693
- 3021008900
- 3022142628
- 2032521
- 1057425
- 3006001176
- 3010846112
- 3002807112
- 3006395932
- 1531174
- 3015207155
- 3002807408
- 3010047454
- 3013194153
- 3006356043
- 3007051929
- 3002807314
- 3009888740
- 1828464
- 3009173317
- 2242737
- 3006946279
- 3002806603
- 3026776
- 3013055499
Source Documents#
Other 510(k) Records For Product Code LZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 |
| 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 |
Legacy Summary#
summary
FDA Review#
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