510(k) K050398
- Device
- EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
- Applicant
- EXACTECH, INC.
- 510(k) number
- K050398
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-18
- Date received
- 2005-02-16
- 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
- Lisa Simpson
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3004493876
- 3010314800
- 3006536454
- 1835831
- 3010155661
- 2242737
- 1836357
- 1828464
- 1526534
- 1818910
- 3002807314
- 3002806603
- 1000294921
- 2528981
- 3003541440
- 3012425419
- 1721676
- 3015167917
- 3011015572
- 3008421730
- 3010039400
- 1720929
- 1424263
- 3004748528
- 9681465
- 9614209
- 3006128100
- 3003477135
- 3010531069
- 3007311878
- 3009973336
- 3004371426
- 9616671
- 1833986
- 3005551626
- 3002806470
- 3036773273
- 2249615
- 2648920
- 3008824097
- 3014833750
- 3004635447
- 9616680
- 3033509898
- 1822565
- 3006946276
- 3014273644
- 3015259876
- 1825034
- 3020155054
- 3043543260
- 3010178296
- 9610726
- 1226188
- 1834379
- 3006001176
- 3003595343
- 3003791208
- 3007391088
- 3007740680
- 3004513872
- 1833920
- 3000258338
- 3009732568
- 3004153240
- 3007923096
- 1038671
- 3035366890
- 2183744
- 3005751028
- 3008544874
- 1220477
- 3008793310
- 3008556682
- 3016438761
- 1057425
- 3015516266
- 3000264985
- 3014315560
- 3007200272
Source Documents#
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 |
Legacy Summary#
summary
FDA Review#
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