Skip to content

APEX 3D Total Ankle Replacement System P10-844-FTPP

by Paragon 28

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889795154026 UDI-DI Date19 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
APEX 3D Total Ankle Replacement System
Generic Name
Bone-coring punch, reusable
Model / Ref / Catalog
P10-844-FTPP
Primary DI / UDI-DI
00889795154026
510(k) Number
FDA Product Code
HSN
GMDN Term
Bone-coring punch, reusable
Device Class
Class II
Regulation Number
888.3110
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K192994)

Show all (12)

Other devices from Paragon 28

See all devices from Paragon 28 →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No