Link Giebel Blade Plate System
FDA 510(k) K895507 · Link America, Inc.
510(k) numberK895507
Submission
- Device name
- Link Giebel Blade Plate System
- Applicant
- Link America, Inc.
East Hanavor, NJ, US - Received
- September 11, 1989
- Decision date
- March 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
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| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K972760 | Link, Acetabular Revision Mesh CupJDJ · Traditional | 10/22/1997SE |
| K964458 | Ellis External Mini-Fixator SystemKTT · Traditional | 12/09/1996SE |
| K955296 | Link MP Reconstruction HipJDI · Traditional | 02/14/1996SE |
| K954186 | Sled Unicompartment Knee SystemHSX · Traditional | 01/26/1996SE |
| K931571 | Link Ceramic Heads 12/14 X 32MMLZO · Traditional | 04/19/1994SN |
| K931572 | Link Ceramic Heads 14/16 X 32MMLZO · Traditional | 03/28/1994SE |
| K920756 | Feldmuhle Ceramic HeadLZO · Traditional | 05/18/1992SE |
| K914804 | Radius Osteotomy PlatesHRS · Traditional | 04/29/1992SN |
| K914803 | Schwabe Radius PlatesHRS · Traditional | 04/28/1992SE |
| K873507 | Link (R) American-Type Bone Staple SystemJDR · Traditional | 09/16/1987SE |
Questions and answers
When was Link Giebel Blade Plate System cleared by the FDA?
Link Giebel Blade Plate System (K895507) received a 510(k) decision of Substantially Equivalent on March 13, 1990, 183 days after the submission was received.
What is the product code of K895507?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.