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Aspen Mis Fusion System

FDA UDI

Class II (US FDA UDI)

by Biomet Spine Llc

Identity

Trade Name
ASPEN MIS FUSION SYSTEM FDA UDI
Generic Name
Interspinous spinal fixation implant FDA UDI
Model / Reference
6213-0008-003 FDA UDI

Identifiers

Catalog Number
6213-0008-003 FDA UDI
Primary DI / UDI-DI
00888480522744 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Interspinous spinal fixation implant

Aspen Mis Fusion System by Biomet Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Interspinous spinal fixation implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Spine Llc

Sources (1)

  • FDA UDI 9f4d8f9f-df33-41c8-a5a3-621dc818252e 35 fields · synced May 30, 2026