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Armada 7453050

by NuVasive, LLC

Armada 7453050 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K112709 on 9 Feb 2012 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00887517484345), active as of 22 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 22 Oct 2026

Documents

510(k) K112709

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887517484345 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112709 Date9 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112709 decided 9 Feb 2012 Active
  • FDA GUDID UDI-DI 00887517484345 listed 11 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112709
  2. Listed FDA GUDID 00887517484345

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Armada
Generic name
Bone tap, reusable
Model / reference
7453050
Primary DI / UDI-DI
00887517484345
510(k) Number
FDA product code
ETN
GMDN term
Bone tap, reusable
Device class
Class II
Regulation number
874.1820
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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See all devices from NuVasive, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)