510(k) K252067
- Device
- Velora Acetabular System
- Applicant
- Restor3D, Inc.
- 510(k) number
- K252067
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-05
- Date received
- 2025-07-01
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Knox Pittman
- Address
- 4001 Nc-54 Hwy. Suite 3160 Durham NC US 27709 27709
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00840097535647 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097536040 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535548 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535463 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535425 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097532226 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535456 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535531 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535494 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535470 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097536033 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535616 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535579 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535555 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535609 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097536026 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535661 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535623 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535524 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535432 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535418 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535500 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097536019 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535586 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535562 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535654 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535487 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535449 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535630 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
| 00840097535593 | Velora Acetabular System Instrumentation | Restor3d, Inc. | 2025-12-15 |
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|---|
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| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025-01-22 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025-01-13 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024-11-08 |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 2024-10-11 |