Identity
- Trade Name
- InSpan FDA UDI
- Generic Name
- Interspinous spinal fixation implant FDA UDI
- Device Name
- SLIM, INSPAN, ISP PLATE ASSEMBLY FDA UDI
- Model / Reference
- 01-61100-1643 FDA UDI
- Description
- SLIM, INSPAN, ISP PLATE ASSEMBLY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190361024644 FDA UDI
- 510(k) Number
- K102020 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Interspinous spinal fixation implant 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
- Width — 16 Millimeter FDA UDILength — 43 Millimeter FDA UDI
Category: Interspinous spinal fixation implant
InSpan by Spinefrontier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interspinous spinal fixation implant.
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II
Cleared under the same submission
K102020 also covers:
- InSpan — SPINEFRONTIER, INC.
- InSpan — SPINEFRONTIER, INC.
- InSpan — SPINEFRONTIER, INC.
- InSpan — SPINEFRONTIER, INC.
- InSpan — SPINEFRONTIER, INC.
- InSpan — SPINEFRONTIER, INC.
- InSpan® — SPINEFRONTIER, INC.
- InSpan® — SPINEFRONTIER, INC.
- InSpan® — SPINEFRONTIER, INC.
- InSpan® — SPINEFRONTIER, INC.
- InSpan® — SPINEFRONTIER, INC.
- InSpan® — 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 0d3312ed-fa67-4366-ad12-d046f683e6fb 36 fields · synced May 30, 2026