← Back to catalogue
Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian) FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- The BluStone Synergy Obsidian 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 Obsidian TLIF implant inserter/pusher 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
- 9100-TI01 FDA UDI
- Description
- The BluStone Synergy Obsidian 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 Obsidian TLIF implant inserter/pusher 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
- 00810482031382 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
- Lumen/Inner Diameter — 0.218 Inch FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian) by Blustone Synergy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blustone Synergy
Sources (1)
- FDA UDI c3213c5f-e825-4600-8c0e-96a9d96b3829 35 fields · synced Jun 1, 2026