FDA.reportPublic FDA data

HYALEX Slalom™ MTP Hemiarthroplasty System

Primary DI
G712PN007840
Brand
HYALEX Slalom™ MTP Hemiarthroplasty System
Company
Hyalex Orthopaedics, Inc.
Model
PN-00784
Catalog number
PN-00784
Device description
HYALEX Slalom™ MTP Hemiarthroplasty Instrument Tray
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWDProsthesis, Toe, Hemi-, Phalangeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250074000HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.2026-04-03KWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G712PN007840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-778-3230customerservice@hyalex.com

Regulatory Flags#

DUNS number
080784794
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G712PN00720100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00720-10PN-00720-102026-06-05
G712PN00720120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00720-12PN-00720-122026-06-05
G712PN00734100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00734-10PN-00734-102026-06-05
G712PN00734120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00734-12PN-00734-122026-06-05
G712PN00763100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00763-10PN-00763-102026-06-05
G712PN00763120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00763-12PN-00763-122026-06-05
G712PN007641HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00764PN-007642026-06-05
G712PN00765100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00765-10PN-00765-102026-06-05
G712PN00765120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00765-12PN-00765-122026-06-05
G712PN00774100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00774-10PN-00774-102026-06-05
G712PN00774120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00774-12PN-00774-122026-06-05
G712PN00777100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00777-10PN-00777-102026-06-05
G712PN00777120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00777-12PN-00777-122026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G712PN00720100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00720120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007641HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
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