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Discectomy Set

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Discectomy Set FDA UDI
Generic Name
Spinal intraoperative positioning pin, reusable FDA UDI
Device Name
Penfield, Distractor #4 FDA UDI
Model / Reference
15-02-03 FDA UDI
Description
Penfield, Distractor #4 FDA UDI

Identifiers

Catalog Number
303-0099 FDA UDI
Primary DI / UDI-DI
M7403030099 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Spinal intraoperative positioning pin, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Spinal intraoperative positioning pin, reusable

Discectomy Set by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal intraoperative positioning pin, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 5965cdf6-b8da-4afb-aa2a-63c2a639feaa 35 fields · synced May 30, 2026