Identity
- Trade Name
- BEE Cage FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- BEE Cages were especially adapted to the local anatomy to secure the surgical outcome at the best. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The cage disposes of 4 pins on both bone facing surfaces, which serve the primary fixation. BEE implants are made of titanium alloy (Ti6Al4V) according to ASTM F 3001. BEE Cages are produced with selective laser melting (SLM) technique. It is not allowed to use BEE implants in contact with components of other manufacturers with the exception of bone graft substitutes or fillers. FDA UDI
- Model / Reference
- BEE Cage cervical 10 x 16 mm 12° S FDA UDI
- Description
- BEE Cages were especially adapted to the local anatomy to secure the surgical outcome at the best. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The cage disposes of 4 pins on both bone facing surfaces, which serve the primary fixation. BEE implants are made of titanium alloy (Ti6Al4V) according to ASTM F 3001. BEE Cages are produced with selective laser melting (SLM) technique. It is not allowed to use BEE implants in contact with components of other manufacturers with the exception of bone graft substitutes or fillers. FDA UDI
Identifiers
- Catalog Number
- B1016L12S FDA UDI
- Primary DI / UDI-DI
- 04251631415121 FDA UDI
- 510(k) Number
- K200429 FDA UDI
- FDA Product Code
- ODP 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 Cage by NGMedical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metallic spinal interbody fusion cage.
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Cleared under the same submission
K200429 also covers:
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE Cage — NGMedical GmbH
- BEE 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 d68e5a3e-7b1d-40ca-a929-f9bc23aac8a7 37 fields · synced Jun 1, 2026