Identity
- Trade Name
- Integra Expandable Interbody FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- 10mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. FDA UDI
- Model / Reference
- 98-2110 FDA UDI
- Description
- 10mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. FDA UDI
Identifiers
- Catalog Number
- 98-2110 FDA UDI
- Primary DI / UDI-DI
- 10889981049485 FDA UDI
- 510(k) Number
- K133418 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
Yes
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
Integra Expandable Interbody by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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- Calibrate — ALPHATEC SPINE, INC. · Class II
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
- General Instruments — ALPHATEC SPINE, INC. · Class I
- Tritanium X — Stryker Corp. · Class I
Cleared under the same submission
K133418 also covers:
- Integra Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
- SeaSpine Expandable Interbody — SeaSpine Orthopedics Corporation
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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 93f7aab2-0030-4e21-b344-d0771ffddca3 37 fields · synced Jun 8, 2026