510(k) K965002
- Device
- ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
- Applicant
- ENCORE ORTHOPEDICS, INC.
- 510(k) number
- K965002
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-27
- Date received
- 1996-12-16
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ASHLEY M BOCK
- Address
- 8900 Shoal Creek Blvd., Bldg. 300 Austin TX US 78757 78757
FDA Registration Numbers#
- 3010375065
- 2245304
- 9616671
- 3004748528
- 3009173317
- 1526711
- 3010132111
- 3005913274
- 1834379
- 3016438694
- 3030412764
- 3003761012
- 3003541440
- 2648920
- 3003595343
- 3005562917
- 3011295718
- 3003477135
- 1020279
- 3011170410
- 3008868758
- 1000200989
- 3009888740
- 3005551626
- 3005751028
- 3006536454
- 3011015572
- 1226544
- 3008824097
- 3002806535
- 3009959868
- 8044172
- 3010468876
- 3011274144
- 3014315560
- 3013413393
- 2030624
- 3009106092
- 1531174
- 3000264985
- 3004641308
- 3002807408
- 1064858
- 3010220595
- 3010163695
- 3010039400
- 3010206549
- 3011189525
- 3006809628
- 3009973336
- 3017397663
- 3027484613
- 3014302784
- 3014833750
- 3036773273
- 1530390
- 1722511
- 1822565
- 3000236920
- 3020155054
- 2183744
- 3010057495
- 3007200272
- 3013194153
- 2249615
- 1529009
- 8043792
- 3004142400
- 9614209
- 2032521
- 3012725451
- 1000547811
- 9681642
- 3014272734
- 3016438761
- 3008102042
- 1450662
- 1221763
- 3015398319
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases