FDA.report

MINIMA S

Primary DI
08033390256063
Brand
MINIMA S
Company
LIMACORPORATE SPA
Model
4503.21.03L
Catalog number
4503.21.03L
Device description
Minima S Standard Hip Stem #3 H. 88 mm Taper 12/14
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Product Code Classifications

CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Premarket Submissions

SubmissionSupplement
K231925000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231925000MINIMA S SystemLima Corporate S.P.A.2023-07-11LZO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390256063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033390256063080333902560638033390256063

GMDN Terms

TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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
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
false

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