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Smart SPACE SHOULDER

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
Smart SPACE SHOULDER FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
Smart SPACE SHOULDER - PLANNER US WIN v.3.3 FDA UDI
Model / Reference
v. 3.3 FDA UDI
Description
Smart SPACE SHOULDER - PLANNER US WIN v.3.3 FDA UDI

Identifiers

Catalog Number
T.285.SSS.0.03 FDA UDI
Primary DI / UDI-DI
08033390248570 FDA UDI
510(k) Number
K222405 FDA UDI
FDA Product Code
QHE FDA UDI
KWS FDA UDI
MBF FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3670 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic/craniofacial implantation planning software

Smart SPACE SHOULDER by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Cleared under the same submission

K222405 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI abeb8082-9821-4fca-839d-ada236cb85be 35 fields · synced Jun 8, 2026