FDA.report

Smart SPACE SHOULDER

Primary DI
08033390236997
Brand
Smart SPACE SHOULDER
Company
LIMACORPORATE SPA
Model
0023.R1.N33.A
Catalog number
0023.R1.N33.A
Device description
Smart SPACE SHOULDER - Glenoid Anatomical Model-RIGHT1-NOT STER
Published
2023-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
QHEShoulder Arthroplasty Implantation System

Product Code Classifications

CodeDeviceSpecialtyClass
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K222405000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222405000Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.2022-12-20QHE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390236997PrimaryGS10

GMDN Terms

TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
432066322
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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