Facet Fixation

FDA UDI

Class I (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Facet Fixation FDA UDI
Generic Name: Fascial tissue dilator, reusable FDA UDI
Device Name: Medium Dilator FDA UDI
Model / Reference: 95-8018 FDA UDI
Description: Medium Dilator FDA UDI

Identifiers

Catalog Number: 95-8018 FDA UDI
Primary DI / UDI-DI: 10889981100575 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Fascial tissue dilator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fascial tissue dilator, reusable

Facet Fixation by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Precept — Nuvasive, Inc. · Class II
MIP Minimal Invasive PCNL — Karl Storz GmbH & Co. KG · Class II
NVM5 — Nuvasive, Inc. · Class II
Precept — Nuvasive, Inc. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 3ab63434-9e36-4c55-a7aa-e66269dd369a 35 fields · synced Jun 8, 2026