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Lima PSI

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name
Lima PSI FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Lima MRI TKA tibia guide FDA UDI
Model / Reference
KNM-LM01-02-01 FDA UDI
Description
Lima MRI TKA tibia guide FDA UDI

Identifiers

Catalog Number
KNM-LM01-02-01 FDA UDI
Primary DI / UDI-DI
E314KNMLM0102010 FDA UDI
510(k) Number
K162273 FDA UDI
K221337 FDA UDI
FDA Product Code
JWH FDA UDI
MBH FDA UDI
OIY FDA UDI
OOG FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

Lima PSI by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Cleared under the same submission

K162273 also covers:

K221337 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA UDI b949b53d-293e-45b4-93e6-097a7c17b46b 35 fields · synced May 30, 2026