Identity
- Trade Name
- IB3D™ PL Spinal System FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- INSERTER A24000000 IB3D IMPLANT FDA UDI
- Model / Reference
- A24000000 FDA UDI
- Description
- INSERTER A24000000 IB3D IMPLANT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03613720286677 FDA UDI
- 510(k) Number
- K241164 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable 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
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: Orthopaedic inorganic implant inserter/extractor, reusable
IB3D™ PL Spinal System by Medicrea International SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
Cleared under the same submission
K241164 also covers:
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
- IB3D™ PL Spinal System — Medicrea International SA
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
- Medicrea International SA
Sources (1)
- FDA UDI 601a7c8e-44c9-46e3-82f4-460dd3464a23 35 fields · synced May 30, 2026