Polymer Threaded Anchor / Suture Combination
FDA 510(k) K982963 · Orthopaedic Biosystems, Ltd.
510(k) numberK982963
Submission
- Device name
- Polymer Threaded Anchor / Suture Combination
- Applicant
- Orthopaedic Biosystems, Ltd.
Scottsdale, AZ, US - Received
- August 24, 1998
- Decision date
- November 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| 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 |
|---|---|---|
| K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01JDR · Special | 04/03/2000SE |
| K982996 | Polymer Obl SB Anchor / Suture CombinationJDR · Traditional | 03/04/1999SE |
| K983169 | Polymer Threaded AnchorMBI · Traditional | 12/16/1998SE |
| K972326 | Peba Anchor/Suture CombinationMBI · Traditional | 02/06/1998SE |
| K963420 | Cancellous Screw WasherHTN · Traditional | 11/15/1996SE |
| K963432 | Guide Wires for Cannulated ScrewsLXT · Traditional | 11/13/1996SE |
| K963433 | Threaded Fixation PinJDW · Traditional | 11/06/1996SE |
| K962779 | Compression ScrewHWC · Traditional | 08/23/1996SN |
| K951451 | Peba Anchor (Multiple Sizes)MBI · Traditional | 10/31/1995SN |
| K942889 | SB AnchorJDR · Traditional | 08/25/1995SE |
Questions and answers
When was Polymer Threaded Anchor / Suture Combination cleared by the FDA?
Polymer Threaded Anchor / Suture Combination (K982963) received a 510(k) decision of Substantially Equivalent on November 20, 1998, 88 days after the submission was received.
What is the product code of K982963?
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.