Identity
- Trade Name
- Blustone Synergy Lumbar PLIF Inserter (Basalt) FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- The BluStone Synergy Basalt System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The Basalt PLIF implant inserter is designed to allow for disassembly during cleaning and sterilization. Instructions regarding disassembly, cleaning and sterilization of the inserter/pusher instrument are provided in the product insert. FDA UDI
- Model / Reference
- 9200-PI01 FDA UDI
- Description
- The BluStone Synergy Basalt System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The Basalt PLIF implant inserter is designed to allow for disassembly during cleaning and sterilization. Instructions regarding disassembly, cleaning and sterilization of the inserter/pusher instrument are provided in the product insert. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810482031405 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 9.89 Inch FDA UDILumen/Inner Diameter — 0.201 Inch FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
Blustone Synergy Lumbar PLIF Inserter (Basalt) by Blustone Synergy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Blustone Synergy
Sources (1)
- FDA UDI d045b578-a9e1-4587-8144-59b6109146f5 35 fields · synced May 30, 2026