Concept 4MM Cancellous Screw with Eyelet
FDA 510(k) K924941 · Linvatec Corp.
510(k) numberK924941
Submission
- Device name
- Concept 4MM Cancellous Screw with Eyelet
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- September 30, 1992
- Decision date
- June 4, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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 |
|---|---|---|
| K092998 | Conmed Linvatec Intercept ImplantMBI · Traditional | 12/23/2009SE |
| K091549 | Conmed Linvatec Soft Tissue to Bone SystemMBI · Special | 06/23/2009SE |
| K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRMAI · Traditional | 06/22/2009SE |
| K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 Hi-Fi SuturesMAI · Special | 04/10/2009SE |
| K083281 | El Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…GEI · Traditional | 02/25/2009SE |
| K060198 | Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and…HRX · Special | 05/11/2006SE |
| K060270 | Micropower Hand Piece: Oral Max High Speed DrillDZI · Special | 04/10/2006SE |
| K060260 | Micropower Hand Piece High Speed DrillHBC · Special | 04/10/2006SE |
| K050519 | Advanced Turbo Drive SystemGEY · Special | 05/17/2005SE |
| K050497 | Bioscrew Xtralok, 8X35MM & 8X40MM VioletHWC · Special | 03/25/2005SE |
Questions and answers
When was Concept 4MM Cancellous Screw with Eyelet cleared by the FDA?
Concept 4MM Cancellous Screw with Eyelet (K924941) received a 510(k) decision of Substantially Equivalent on June 4, 1993, 247 days after the submission was received.
What is the product code of K924941?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.