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EIT PLIF Shaver

FDA UDI

Class I (US FDA UDI)

by EIT Emerging Implant Technologies GmbH

Identity

Trade Name
EIT PLIF Shaver FDA UDI
Generic Name
Orthopaedic chisel FDA UDI
Device Name
Shaver, H 8mm FDA UDI
Model / Reference
PFT10800 FDA UDI
Description
Shaver, H 8mm FDA UDI

Identifiers

Primary DI / UDI-DI
04260397082874 FDA UDI
510(k) Number
K170503 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic chisel 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic chisel

EIT PLIF Shaver by EIT Emerging Implant Technologies GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic chisel.

Cleared under the same submission

K170503 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EIT Emerging Implant Technologies GmbH

Sources (1)

  • FDA UDI 2b458907-dd3c-4e23-a09e-deb8fa7fc5ab 34 fields · synced May 30, 2026