BEE PLIF Cage— 510(k) K261067
Substantially EquivalentNGMedical GmbH
FDA 510(k) clearance K261067 for BEE PLIF Cage, Substantially Equivalent on 2026-04-30. Applicant: NGMedical GmbH. Device class: 2.
Summary
NGMedical's BEE PLIF Cage is filed under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar). The record doesn't describe the cage beyond its name and that code name.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).
NGMedical filed from Nonnweiler, Germany. The record shows 29 calendar days from receipt to decision (April 1 to April 30, 2026).
Clearance details
- Applicant
- NGMedical GmbH
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Nonnweiler, DE
Recent devices under product code MAX
view allMore clearances from NGMedical GmbH
view allAdverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.