Identity
- Trade Name
- Ø7.5mm x 55mm Pedicle Screw with Set Screw Package FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- XM-215-7555 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B064XM21575551 FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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: Spinal bone screw, non-bioabsorbable
Ø7.5mm x 55mm 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 Spinal bone screw, non-bioabsorbable.
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- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, 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 9ff9c498-e528-41f9-9ba3-87b732d56d0b 32 fields · synced Jun 8, 2026