510(k) K193545
- Device
- Corin Optimized Positioning System (OPS) Femoral
- Applicant
- Corin USA
- 510(k) number
- K193545
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-04
- Date received
- 2019-12-20
- 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
- Lucinda Gerber
- Address
- 12750 Citrus Park Ln. Suite 120 Tampa FL US 33625 33625
FDA Registration Numbers#
- 3010097171
- 3014302784
- 1226188
- 3014273644
- 3004493876
- 3004638532
- 3007334927
- 3006001176
- 3007120646
- 1424263
- 3010314800
- 3003761012
- 3010220595
- 3035366890
- 1000577893
- 9617840
- 1825034
- 3015207155
- 3010009693
- 3013450937
- 3043543260
- 9615800
- 3014252644
- 1218882
- 3007913880
- 3007051929
- 3002807112
- 3005180920
- 3003791208
- 3010178296
- 9614209
- 3013791180
- 3012439458
- 1057425
- 3006356043
- 1722511
- 9616944
- 3012130008
- 3008102042
- 3010206549
- 3000264985
- 3012319330
- 3038503932
- 3012425419
- 3016438761
- 3000258338
- 3002807295
- 2242737
- 1043653
- 3005913274
- 2249697
- 3008395353
- 3004188066
- 3009756327
- 1833920
- 3010057495
- 3004153240
- 3021386586
- 3008812251
- 1000200989
- 3005551626
- 3012916784
- 1000547811
- 3009760038
- 3013014058
- 3010576282
- 3026776
- 3016778562
- 3010287737
- 3013176080
- 3010375065
- 3004748528
- 3008868758
- 3020155054
- 3015542154
- 3004641308
- 3010288357
- 9681465
- 1833506
- 3012329926
Source Documents#
Other 510(k) Records For Product Code LZO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243029 | Origin™ TT Stem | Signature Orthopaedics Pty, Ltd. | 2025-03-11 |