FDA.report

Smart SPACE SHOULDER

Primary DI
08033390248570
Brand
Smart SPACE SHOULDER
Company
LIMACORPORATE SPA
Model
v. 3.3
Catalog number
T.285.SSS.0.03
Device description
Smart SPACE SHOULDER - PLANNER US WIN v.3.3
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
false

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
08033390248570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033390248570080333902485708033390248570

GMDN Terms

TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods

Method

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
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19
08033390002257SMR System1362.09.0201362.09.0202026-02-19
08033390050029SMR System1362.09.1151362.09.1152026-02-19
08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19
08033390202466PRIMA1367.09.2731367.09.2732026-02-19
08033390202473PRIMA1367.09.2761367.09.2762026-02-19
08033390202480PRIMA1367.09.4031367.09.4032026-02-19
08033390202497PRIMA1367.09.4061367.09.4062026-02-19
08033390202503PRIMA1367.09.3001367.09.3002026-02-19
08033390202602PRIMA1367.09.3031367.09.3032026-02-19
08033390202619PRIMA1367.09.3061367.09.3062026-02-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05404028001110SurgiCase Planner Materialise NVQHE2025-12-17
05404028001028SurgiCase Planner Materialise NVQHE2025-08-28
00810022403051CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403068CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403099CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403105CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403129CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403136CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403143CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403150CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403167CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403174CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403181CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403198CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403204CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00888867498969Arthrex®ARTHREX, INC.QHE2025-05-01
05420060366116Match Point SystemMaterialise NVQHE2024-12-09
05420060366123Match Point SystemMaterialise NVQHE2024-12-09
00888867264953Arthrex®ARTHREX, INC.QHE2024-09-03
00888867392274Arthrex®ARTHREX, INC.QHE2023-04-24
08033390201858Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390201872Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390201896Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390201919Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390201933Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390201957Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390236997Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390237000Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390237017Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18
08033390237024Smart SPACE SHOULDERLIMACORPORATE SPAQHE2023-02-18