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Inspire Porous PEEK Cervical Interbody Fusion System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Inspire Porous PEEK Cervical Interbody Fusion System FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Vise Cervical Inserter, 0mm Stop FDA UDI
- Model / Reference
- C235-100-0 FDA UDI
- Description
- Vise Cervical Inserter, 0mm Stop FDA UDI
Identifiers
- Primary DI / UDI-DI
- B648C23510000 FDA UDI
- 510(k) Number
- K213030 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
No
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
- Depth — 0 Millimeter FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Inspire Porous PEEK Cervical Interbody Fusion System by Curiteva, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Cleared under the same submission
K213030 also covers:
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
- Inspire Porous PEEK Cervical Interbody Fusion System — Curiteva, LLC
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
- Curiteva, LLC
Sources (1)
- FDA UDI 8045e36b-efcb-4cf7-9a09-76260d857425 36 fields · synced Jun 8, 2026