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Constrictor® Button Extender AB-2275

by Dunamis Medical LLC

Constrictor® Button Extender AB-2275 is a Class II device made by Dunamis Medical LLC, cleared under FDA 510(k) K191319 on 29 Aug 2019 and listed in FDA GUDID since 11 Aug 2023 (UDI-DI 10854629006809), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K191319

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10854629006809 UDI-DI Date11 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191319 Date29 Aug 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191319 decided 29 Aug 2019 Active
  • FDA GUDID UDI-DI 10854629006809 listed 11 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191319
  2. Listed FDA GUDID 10854629006809

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Constrictor® Button Extender
Generic name
Orthopaedic bone washer, sterile
Model / Ref / Catalog
AB-2275
Primary DI / UDI-DI
10854629006809
510(k) Number
FDA product code
HTN
GMDN term
Orthopaedic bone washer, sterile
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)