FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUCENT MAGNUM+
K Number: K081711
·
Decision Sep 11, 2008
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
49
Review Days
86
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Basic Information
- Device Name
- LUCENT MAGNUM+
- K Number
- K081711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Elements, Inc.
- Date Received
- June 17, 2008
- Decision Date
- September 11, 2008
- Product Code
- OVD
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K242527 | The Karma® Fixation System | May 21, 2025 | Substantially Equivalent |
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| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | Jun 30, 2021 | Substantially Equivalent |