510(k) K011836
- Device
- MPF ACETABULAR CUP
- Applicant
- PLUS ORTHOPEDICS
- 510(k) number
- K011836
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-07
- Date received
- 2001-06-12
- 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
Applicant Contact#
- Contact
- HARTMUT LOCH
- Address
- 6055 Lusk Blvd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3010041693
- 1720929
- 3034676720
- 3010206549
- 3025603301
- 3009475821
- 3014273644
- 3013413393
- 3008812251
- 1000200989
- 1220477
- 2245304
- 3008281151
- 1000577893
- 3010220595
- 3009732568
- 3021008900
- 1047843
- 1833506
- 3005333358
- 1226188
- 3011189525
- 3002498892
- 2030624
- 9615800
- 2648920
- 3006001176
- 3001278222
- 1644408
- 3003541440
- 1038671
- 3010468876
- 3009998573
- 3002807295
- 3009813841
- 3020967480
- 3008556682
- 3010039400
- 3003791208
- 3011683674
- 2246552
- 8010379
- 3012329926
- 1000294921
- 1218882
- 3009756327
- 2242737
- 3022142628
- 3008793310
- 3004153240
- 3002807408
- 3014315560
- 9610612
- 1057425
- 3007913880
- 1834331
- 1020279
- 1835444
- 3012523063
- 3013194153
- 1835831
- 3010386387
- 3014252644
- 3008824097
- 3006946279
- 3005551626
- 3015167917
- 1643817
- 3004153896
- 3004638532
- 3008668801
- 3012425419
- 2244478
- 3007051929
- 3015398319
- 3010120135
- 1818910
- 3010163695
- 3003595343
- 3011274144
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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