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Impulse Interbody Spacer System

FDA UDI

Class II (US FDA UDI)

by Degen Medical

Identity

Trade Name
Impulse Interbody Spacer System FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
13H X 26L X 8W Impulse Anatomic Trial FDA UDI
Model / Reference
07-02T1326A FDA UDI
Description
13H X 26L X 8W Impulse Anatomic Trial FDA UDI

Identifiers

Catalog Number
07-02T1326A FDA UDI
Primary DI / UDI-DI
00842048134220 FDA UDI
510(k) Number
K201287 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Spinal implant trial 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

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

Dimensions & Sizes

Size
Length — 26 Millimeter FDA UDI
Height — 13 Millimeter FDA UDI
Width — 8 Millimeter FDA UDI

Category: Spinal implant trial

Impulse Interbody Spacer System by Degen Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K201287 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Degen Medical

Sources (1)

  • FDA UDI 57d50e0a-5ac7-4bb7-96d8-47ed608bfebe 37 fields · synced May 30, 2026