FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BEE PLIF Cage
K Number: K261067
·
Decision Apr 30, 2026
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
7
Review Days
29
Basic Information
- Device Name
- BEE PLIF Cage
- K Number
- K261067
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NGMedical GmbH
- Date Received
- April 1, 2026
- Decision Date
- April 30, 2026
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by NGMedical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K250560 | BEE HA | Nov 21, 2025 | Substantially Equivalent |
| K231371 | BEE Cervical Cage | Jan 12, 2024 | Substantially Equivalent |
| K212050 | NGM WAVE PLIF Cage | Dec 1, 2021 | Substantially Equivalent |
| K211413 | BEE PLIF Cage | Aug 27, 2021 | Substantially Equivalent |
| K203444 | BEE HA Cage | Mar 18, 2021 | Substantially Equivalent |
| K200429 | BEE Cages | Jan 29, 2021 | Substantially Equivalent |