Round Staple
FDA 510(k) K905364 · O'Tec Corp.
510(k) numberK905364
Submission
- Device name
- Round Staple
- Applicant
- O'Tec Corp.
Memphis, TN, US - Received
- November 28, 1990
- Decision date
- December 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K943293 | SCC22/ SCC26 Shower Commode ChairIOR · Traditional | 08/19/1994SE |
| K910093 | Futura Femoral Hip StemJDI · Traditional | 07/01/1991SE |
| K905358 | Cancellous ScrewHWC · Traditional | 01/04/1991SN |
| K905357 | Cortical Bone Screw (European Style)HWC · Traditional | 01/04/1991SN |
| K905355 | Broad Self-Compressing PlateHRS · Traditional | 01/04/1991SN |
| K905347 | Hagie PinJDW · Traditional | 01/04/1991SN |
| K905333 | U.S. Type Cruciate Slot Bone ScrewHWC · Traditional | 01/04/1991SN |
| K905363 | Fixation StapleJDR · Traditional | 12/11/1990SE |
| K905362 | Barbed Square StapleJDR · Traditional | 12/11/1990SE |
| K905352 | Blade PlateKTT · Traditional | 12/11/1990SE |
Questions and answers
When was Round Staple cleared by the FDA?
Round Staple (K905364) received a 510(k) decision of Substantially Equivalent on December 11, 1990, 13 days after the submission was received.
What is the product code of K905364?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.