Identity
- Trade Name
- KeyLift™ FDA UDI
- Generic Name
- Lumbar decompression interspinous spacer FDA UDI
- Device Name
- KeyLift XL 20mm Lg x 10mm H FDA UDI
- Model / Reference
- KeyLift™ FDA UDI
- Description
- KeyLift XL 20mm Lg x 10mm H FDA UDI
Identifiers
- Catalog Number
- 07-1220-010 FDA UDI
- Primary DI / UDI-DI
- B1830712200100 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Millimeter FDA UDIHeight — 10 Millimeter FDA UDI
Category: Lumbar decompression interspinous spacer
KeyLift™ by Flospine — 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
- InterBRIDGE — Ldr Spine USA · Class II
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- InterBRIDGE — Ldr Spine USA · Class II
- Superion™ — Boston Scientific Neuromodulation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Flospine
Sources (1)
- FDA UDI 6d1b6c29-1a82-4419-bc9d-a323e33538cb 36 fields · synced Jun 1, 2026