Staple Blade for Tibial Osteo/Staple Blade L'Union

FDA 510(k) K911026 · Sport Service, Inc.

Substantially Equivalent

510(k) numberK911026

Submission

Device name
Staple Blade for Tibial Osteo/Staple Blade L'Union
Applicant
Sport Service, Inc.
Washington, DC, US
Received
March 1, 1991
Decision date
May 29, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JDR – Staple, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code JDR

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K262451Arthrex DynaNite StaplesJDR · Traditional Arthrex, Inc.09/01/2026SE
K261121Megalodon Dynamic Compression SystemJDR · Traditional Paragon 28, Inc.08/06/2026SE
K250712Linkt Compression Staple SystemJDR · Traditional Trax Surgical05/14/2025SE
K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional Medline Industries, LP04/11/2025SE
K243742Arthrex DynaNite Nitinol StaplesJDR · Traditional Arthrex, Inc.01/31/2025SE
K243658TMC Compression Implant SystemJDR · Special Treace Medical Concepts12/26/2024SE
K242415TMC Compression Implant SystemJDR · Special Treace Medical Concepts09/06/2024SE
K240212COGNiTiON™ Staple SystemJDR · Special Ortho Solutions UK , Ltd.02/23/2024SE
K232990A’TOMIC™ Nitinol Fixation SystemJDR · Traditional Rmr Ortho, LLC01/12/2024SE
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional Novastep12/04/2023SE

More from Novastep

510(k)DeviceDecision
K911031The Tramond PinJDR · Traditional 05/29/1991SE
K911021Plate Blade with Cursor of L'UnionKTT · Traditional 05/29/1991SE
K911020Ligamentoplastic Staple of L'UnionJDR · Traditional 05/29/1991SE

Questions and answers

When was Staple Blade for Tibial Osteo/Staple Blade L'Union cleared by the FDA?

Staple Blade for Tibial Osteo/Staple Blade L'Union (K911026) received a 510(k) decision of Substantially Equivalent on May 29, 1991, 89 days after the submission was received.

What is the product code of K911026?

The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.