Identity
- Trade Name
- BEE PLIF Cage FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- BEE®PLIF cages have been specially adapted to suit the local anatomy to ensure the operative outcome to the greatest extent possible. BEE®PLIF cages are made of titanium alloy in accordance with ASTM F3001 and are produced in an additive manufacturing process. The implants are available in various heights, lengths and lordosis angles. The cranial and caudal side of the implant is rough to achieve a good degree of anchoring of the implant. FDA UDI
- Model / Reference
- 10 x 24 mm 0° FDA UDI
- Description
- BEE®PLIF cages have been specially adapted to suit the local anatomy to ensure the operative outcome to the greatest extent possible. BEE®PLIF cages are made of titanium alloy in accordance with ASTM F3001 and are produced in an additive manufacturing process. The implants are available in various heights, lengths and lordosis angles. The cranial and caudal side of the implant is rough to achieve a good degree of anchoring of the implant. FDA UDI
Identifiers
- Catalog Number
- BLP1024L00 FDA UDI
- Primary DI / UDI-DI
- 04251631408260 FDA UDI
- 510(k) Number
- K211413 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Metallic spinal interbody fusion cage
BEE PLIF Cage by NGMedical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal interbody fusion cage.
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- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- MectaLIF 3D — Medacta International · Class II
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- Solar™ Interbody Fusion System — Degen Medical · Class II
- Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K211413 also covers:
- BEE PLIF — NGMedical GmbH
- BEE PLIF — NGMedical GmbH
- BEE PLIF — NGMedical GmbH
- BEE PLIF — NGMedical GmbH
- BEE PLIF — NGMedical GmbH
- BEE PLIF — NGMedical GmbH
- BEE PLIF — NGMedical GmbH
- BEE PLIF Cage — NGMedical GmbH
- BEE PLIF Cage — NGMedical GmbH
- BEE PLIF Cage — NGMedical GmbH
- BEE PLIF Cage — NGMedical GmbH
- BEE PLIF Cage — NGMedical GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- NGMedical GmbH
Sources (1)
- FDA UDI 88d6ca78-7133-4deb-b2d2-aa8a0d0d8573 37 fields · synced May 31, 2026