Identity
- Trade Name
- BLACKBIRD™ Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- UNIV,ROD,PREBENT,TI,3.5X40 FDA UDI
- Model / Reference
- LT40-P040 FDA UDI
- Description
- UNIV,ROD,PREBENT,TI,3.5X40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996107891 FDA UDI
- 510(k) Number
- K133214 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 40 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
The Blackbird Spinal System is a comprehensive, non-sterile internal spinal fixation system designed for orthopedic treatments. Developed by Choice Spine, LP, this product offers a unique combination of anchors, interconnection mechanisms, longitudinal members, and transverse connectors. The system is intended to provide immobilization and stabilization of spinal segments in various conditions, including degenerative disc disease.
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- 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
Cleared under the same submission
K133214 also covers:
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
- BLACKBIRD Spinal System — Choicespine, LP
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Choicespine, LP
Sources (1)
- FDA UDI 157f5e65-2547-41f0-b870-c48d74ee1607 36 fields · synced Jul 11, 2026