SP-LINK System
FDA 510(k) K182352 · Medical Designs, LLC
510(k) numberK182352
Submission
- Device name
- SP-LINK System
- Applicant
- Medical Designs, LLC
Sioux Falls, SD, US - Received
- August 29, 2018
- Decision date
- November 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEK – Spinous Process Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
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| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…PEK · Traditional | Spinal Simplicity, LLC | 12/15/2021SE |
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| K090048 | Asfora Bullet Cage SystemMAX · Traditional | 08/14/2009SE |
| K042359 | Subdural Evacuating Port System Cranial Access Kit (Seps-Ca), (Seps-Cal)…JXG · Traditional | 11/17/2004SE |
| K002970 | Subdural Evacuating Port System, Model 11-9901JXG · Traditional | 12/12/2000SE |
Questions and answers
When was SP-LINK System cleared by the FDA?
SP-LINK System (K182352) received a 510(k) decision of Substantially Equivalent on November 21, 2018, 84 days after the submission was received.
What is the product code of K182352?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.