Identity
- Trade Name
- TYPHOON™Facet Screw Fixation System FDA UDI
- Generic Name
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- TYPHOON,DRILL,FIXED,SOLID,3.0X25 FDA UDI
- Model / Reference
- K070-SD4425 FDA UDI
- Description
- TYPHOON,DRILL,FIXED,SOLID,3.0X25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996131247 FDA UDI
- 510(k) Number
- K121850 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Category: Trans-facet-screw internal spinal fixation system, sterile
TYPHOON™Facet Screw Fixation System by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Trans-facet-screw internal spinal fixation system, sterile.
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Cleared under the same submission
K121850 also covers:
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
- HARRIER™ Choice Spine Intervertebral Body Device — Choicespine, LP
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
- Choicespine, LP
Sources (1)
- FDA UDI 220f4b4d-d7a1-4963-b133-1e78a482a1aa 35 fields · synced May 31, 2026