Identity
- Trade Name
- P-LIFT® FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- Dorado P-LIFT IBC 8-10X30 Straight 11mm FDA UDI
- Model / Reference
- 01-06022-11 FDA UDI
- Description
- Dorado P-LIFT IBC 8-10X30 Straight 11mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190361003243 FDA UDI
- 510(k) Number
- K111553 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
- Width — 8 Millimeter FDA UDILength — 30 Millimeter FDA UDIHeight — 11 Millimeter FDA UDI
Category: Polymeric spinal interbody fusion cage
A comprehensive medical device directory listing the P-LIFT Dorado IBC 8-10X30 Straight 11mm Polymeric Spinal Intervertebral Fusion Device, featuring its key features and regulatory compliance.
Similar devices
Also classified as Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K111553 also covers:
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Spinefrontier, Inc.
Sources (1)
- FDA UDI 3ecb979b-2bd6-4bac-b954-8efb342910d3 36 fields · synced Jul 10, 2026