510(k) K121439
- Device
- METAFIX FEMORAL HIP STEM SIZE 1
- Applicant
- CORIN U.S.A.
- 510(k) number
- K121439
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-14
- Date received
- 2012-05-15
- 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
- 10500 University Center Dr. Suite 190 Tampa FL US 33612 33612
FDA Registration Numbers#
- 1226188
- 1064858
- 1000200989
- 3007913880
- 3007200272
- 9615674
- 3012439458
- 8010379
- 1221053
- 3011170410
- 1530390
- 3013450937
- 3003595343
- 1828288
- 3005551626
- 1220477
- 3035366890
- 3012329926
- 3008793310
- 3004153240
- 3013055499
- 1835572
- 3014273644
- 3010097171
- 1018470
- 3010576282
- 1833986
- 3008812251
- 3010132111
- 3010531069
- 3004513872
- 1825034
- 3010314800
- 1836357
- 3002807295
- 3004493876
- 3007366790
- 3008668801
- 3006801265
- 3005718816
- 3002806603
- 3011015572
- 3001278222
- 3026776
- 3004638532
- 3021008900
- 3013413393
- 3002807112
- 3020967480
- 3008102042
- 3010206549
- 3010386387
- 3003639920
- 3010163695
- 3009871135
- 8044172
- 3042508254
- 3005061536
- 3009756327
- 3003998208
- 3007391088
- 3008556682
- 3008395353
- 3036795922
- 1423662
- 2133928
- 3006001176
- 3002807408
- 3016778562
- 9681642
- 3015516266
- 3008544874
- 3001284227
- 1720929
- 9610612
- 3006128100
- 3009106092
- 1043653
- 1526711
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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