Memograph Staple, Warm System
FDA 510(k) K993714 · Biomedical Ent., Inc.
510(k) numberK993714
Submission
- Device name
- Memograph Staple, Warm System
- Applicant
- Biomedical Ent., Inc.
San Antonio, TX, US - Received
- November 2, 1999
- Decision date
- February 25, 2000
- 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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| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
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| 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 |
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| K133844 | Speed TriadJDR · Special | 04/07/2014SE |
| K133780 | Speed XLJDR · Traditional | 03/19/2014SE |
| K131640 | Smooth or Threaded Metallic Bone FastenerHTY · Traditional | 10/16/2013SE |
| K102107 | Osstaple ChillJDR · Special | 09/03/2010SE |
| K091951 | HammerlockHTY · Traditional | 02/19/2010SE |
| K023203 | OsstapleJDR · Special | 10/17/2002SE |
| K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the…JDR · Traditional | 03/13/2001SE |
| K001353 | Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for…HBW · Traditional | 03/13/2001SE |
| K001219 | Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple SystemJEY · Traditional | 06/21/2000SE |
| K971782 | Bone and Marrow Collection System KitGEY · Traditional | 07/29/1997SE |
Questions and answers
When was Memograph Staple, Warm System cleared by the FDA?
Memograph Staple, Warm System (K993714) received a 510(k) decision of Substantially Equivalent on February 25, 2000, 115 days after the submission was received.
What is the product code of K993714?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.