Identity
- Trade Name
- REFLECT FDA UDI
- Generic Name
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- REFLECT 5.0mm Cord with Collet, 350mm FDA UDI
- Model / Reference
- 1244.1351S FDA UDI
- Description
- REFLECT 5.0mm Cord with Collet, 350mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00193982313470 FDA UDI
- PMA Number
- H210002 FDA UDI
- FDA Product Code
- QHP FDA UDI
- GMDN Term
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Trans-facet-screw internal spinal fixation system, sterile
Reflect by Globus Medical, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trans-facet-screw internal spinal fixation system, sterile.
- FacetFuse® — SPINEFRONTIER, INC. · U
- CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLC · U
- FacetFuse® — SPINEFRONTIER, INC. · U
- JAZZ System — Implanet · Class II
- Concero™ Facet Screw System — BIOMET SPINE LLC · U
- CREO — GLOBUS MEDICAL, INC. · Class II
- CREO — GLOBUS MEDICAL, INC. · Class II
- SI-LOK — GLOBUS MEDICAL, INC. · Class II
Cleared under the same submission
H210002 also covers:
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
- REFLECT — GLOBUS MEDICAL, INC.
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 N | Pending data |
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Manufacturer
- Manufacturer
- Globus Medical, Inc.
Sources (1)
- FDA UDI 839a9c07-4bf2-4363-938e-3f5036e602ce 34 fields · synced May 30, 2026