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HYALEX Slalom™ MTP Hemiarthroplasty System PN-00765-12

by Hyalex Orthopaedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG712PN00765120 UDI-DI Date5 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HYALEX Slalom™ MTP Hemiarthroplasty System
Generic Name
Partial metatarsophalangeal joint prosthesis
Model / Ref / Catalog
PN-00765-12
Primary DI / UDI-DI
G712PN00765120
510(k) Number
FDA Product Code
KWD
GMDN Term
Partial metatarsophalangeal joint prosthesis
Device Class
Class II
Regulation Number
888.3730
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 12 Millimeter

Related devices

Cleared under the same submission (K250074)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No