Identity
- Trade Name
- Ø6.5mm x 27mm Pedicle Screw with Set Screw Package FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Model / Reference
- XM-215-6527 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B064XM21565271 FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- 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
Yes
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
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Polymeric spinal interbody fusion cage
Ø6.5mm x 27mm Pedicle Screw with Set Screw Package by Xenco Medical Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
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- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- S-LIFT® — SPINEFRONTIER, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Xenco Medical Llc
Sources (1)
- FDA UDI 7e9100b1-b8a5-4d98-bd95-db837de0c1b6 32 fields · synced Jun 6, 2026