Link (R) American-Type Bone Staple System
FDA 510(k) K873507 · Link America, Inc.
510(k) numberK873507
Submission
- Device name
- Link (R) American-Type Bone Staple System
- Applicant
- Link America, Inc.
East Hanavor, NJ, US - Received
- August 31, 1987
- Decision date
- September 16, 1987
- 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
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| 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 Link (R) American-Type Bone Staple System cleared by the FDA?
Link (R) American-Type Bone Staple System (K873507) received a 510(k) decision of Substantially Equivalent on September 16, 1987, 16 days after the submission was received.
What is the product code of K873507?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.