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Santis Cannulated Reduction Extra LongPolyaxial Pedicle Screw/Dia.6.5mm/Lng.45mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Santis Cannulated Reduction Extra LongPolyaxial Pedicle Screw/Dia.6.5mm/Lng.45mm FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- Santis Cannulated Reduction Extra LongPolyaxial Pedicle Screw/Dia.6.5mm/Lng.45mm FDA UDI
- Model / Reference
- 901-6545 FDA UDI
- Description
- Santis Cannulated Reduction Extra LongPolyaxial Pedicle Screw/Dia.6.5mm/Lng.45mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159551331 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDINKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
Santis Cannulated Reduction Extra LongPolyaxial Pedicle Screw/Dia.6.5mm/Lng.45mm by Lanterna Medical Technologies — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
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- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lanterna Medical Technologies
Sources (1)
- FDA UDI 6e2a3a22-5dbf-467e-8ec8-d53b2765f986 34 fields · synced Jun 1, 2026