Identity
- Trade Name
- InterBRIDGE FDA UDI
- Generic Name
- Lumbar decompression interspinous spacer FDA UDI
- Device Name
- H6.5mm Insert FDA UDI
- Model / Reference
- IB0065T FDA UDI
- Description
- H6.5mm Insert FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662663004671 FDA UDI
- FDA Product Code
- PEK FDA UDI
- GMDN Term
- Lumbar decompression interspinous spacer 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 6.5 Millimeter FDA UDI
Category: Lumbar decompression interspinous spacer
InterBRIDGE by Ldr Spine USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar decompression interspinous spacer.
- Affix — Nuvasive, Inc. · Class II
- Affix — Nuvasive, Inc. · Class II
- Affix — Nuvasive, Inc. · Class II
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- Superion™ — Boston Scientific Neuromodulation · Class III
- Affix — Nuvasive, Inc. · Class II
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ldr Spine USA
Sources (1)
- FDA UDI dd851502-dbd9-4cb7-be37-1732668a4863 35 fields · synced Jun 8, 2026