Spectron Long, Straight Femoral Prosthes
FDA 510(k) K823722 · Richard'S Medical Equip., Inc.
510(k) numberK823722
Submission
- Device name
- Spectron Long, Straight Femoral Prosthes
- Applicant
- Richard'S Medical Equip., Inc.
Walker, MI, US - Received
- December 10, 1982
- Decision date
- March 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | Biomet, Inc. | 07/01/2026SE |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | Signature Orthopaedics Pty, Ltd. | 03/12/2026SE |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional | Zimmer Biomet | 07/31/2025SE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K830793 | Patient Guided Elbow & Shoulder ExercBXB · Traditional | 06/16/1983SE |
| K823837 | RMC Total Knee SystemMBV · Traditional | 03/29/1983SE |
| K823726 | Spectron Conversion Endoprosthesis CupKWY · Traditional | 03/09/1983SE |
| K823724 | Spectron Neck Replacement ProsthesisJDI · Traditional | 03/09/1983SE |
| K823723 | Spectron Proximal Femoral ProsthesisJDI · Traditional | 03/09/1983SE |
| K823727 | Spectron Primary Stem Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K830153 | Richards Intra-Articular Shaver BladesGEY · Traditional | 02/28/1983SE |
| K830154 | Colles Fracture FrameJEC · Traditional | 02/02/1983SE |
| K823729 | Spectron Metal Back Acetabular ComponentJDI · Traditional | 01/21/1983SE |
| K823728 | Spectron Polyethylene Acctubular ComponJDI · Traditional | 01/21/1983SE |
Questions and answers
When was Spectron Long, Straight Femoral Prosthes cleared by the FDA?
Spectron Long, Straight Femoral Prosthes (K823722) received a 510(k) decision of Substantially Equivalent on March 8, 1983, 88 days after the submission was received.
What is the product code of K823722?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.