FDA.report

Smart SPACE SHOULDER

Primary DI
08033390201933
Brand
Smart SPACE SHOULDER
Company
LIMACORPORATE SPA
Model
0023.R2.N33
Catalog number
0023.R2.N33
Device description
Smart SPACE SHOULDER - Glenoid 3D Positioner-RIGHT2-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
08033390201933PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
08033390201933140803339020193308033390201933Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

GMDN Terms

TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

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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