Howmedica Mainstay Anchor
FDA 510(k) K953531 · Howmedica Corp.
510(k) numberK953531
Submission
- Device name
- Howmedica Mainstay Anchor
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- July 27, 1995
- Decision date
- September 26, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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
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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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Questions and answers
When was Howmedica Mainstay Anchor cleared by the FDA?
Howmedica Mainstay Anchor (K953531) received a 510(k) decision of Substantially Equivalent for Some Indications on September 26, 1995, 61 days after the submission was received.
What is the product code of K953531?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.