LOSPA IS ACP System
FDA 510(k) K161641 · Corentec Co., Ltd.
510(k) numberK161641
Submission
- Device name
- LOSPA IS ACP System
- Applicant
- Corentec Co., Ltd.
Cheonan, KR - Received
- June 14, 2016
- Decision date
- January 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was LOSPA IS ACP System cleared by the FDA?
LOSPA IS ACP System (K161641) received a 510(k) decision of Substantially Equivalent on January 5, 2017, 205 days after the submission was received.
What is the product code of K161641?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.