Polymer Obl SB Anchor / Suture Combination
FDA 510(k) K982996 · Orthopaedic Biosystems, Ltd.
510(k) numberK982996
Submission
- Device name
- Polymer Obl SB Anchor / Suture Combination
- Applicant
- Orthopaedic Biosystems, Ltd.
Scottsdale, AZ, US - Received
- August 27, 1998
- Decision date
- March 4, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01JDR · Special | 04/03/2000SE |
| K983169 | Polymer Threaded AnchorMBI · Traditional | 12/16/1998SE |
| K982963 | Polymer Threaded Anchor / Suture CombinationJDI · Traditional | 11/20/1998SE |
| 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 Obl SB Anchor / Suture Combination cleared by the FDA?
Polymer Obl SB Anchor / Suture Combination (K982996) received a 510(k) decision of Substantially Equivalent on March 4, 1999, 189 days after the submission was received.
What is the product code of K982996?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.