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Sternalock 360 System 74-0003

by Biomet Microfixation, Inc 2 variants

Sternalock 360 System 74-0003 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K163007 on 23 Nov 2016 (1 earlier submission) and listed in FDA GUDID since 30 Jun 2020 (UDI-DI 00888233026598), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888233026598 UDI-DI Date30 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK163007 Date23 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163007 decided 23 Nov 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00888233026598 listed 30 Jun 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151019
  2. Cleared FDA 510(k) K163007
  3. Listed FDA GUDID 00888233026598

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sternalock 360 System
Generic name
Sternal fixation device
Model / Ref / Catalog
74-0003
Primary DI / UDI-DI
00888233026598
510(k) Number
FDA product code
HRS
GMDN term
Sternal fixation device
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Sternal fixation device

Cleared under the same submission (K151019)

and 4 more cleared under K151019

Cleared under the same submission (K163007)

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)