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Monkey Rings™ External Fixation System P45-199-5035-S

by Paragon 28 GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889795126788 UDI-DIDate3 Feb 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Monkey Rings™ External Fixation System
Generic Name
External orthopaedic fixation system, single-use
Model / Ref / Catalog
P45-199-5035-S
Primary DI / UDI-DI
00889795126788
510(k) Number
FDA Product Code
KTT
GMDN Term
External orthopaedic fixation system, single-use
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K212895)

Show all (12)

Other devices from Paragon 28

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Properties

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

Other properties (8)

  • 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