510(k) K181630 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Revolution External Plating System
| Applicant | New Standard Device Dba Metalogix, San Antonio TX, US |
| Decision | Substantially Equivalent, May 29, 2019 |
| Received | Jun 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181630
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2023 | New Standard Device Inc 'n'-Hole Post which is a component of the Revolution External Fixation System
Catalog Numbers:
100801,
100802,
100803,
100804,
100805 Open, Classified |
KTT | None listed |
| Dec 28, 2020 | New Standard Device Inc Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic.
Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030
Metalogix Self-Drill Half-Pin 5x40x215mm RE Open, Classified |
KTT | None listed |
| Jun 8, 2020 | New Standard Device Inc 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System Completed |
KTT | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Hip Joint Replacement Systems, Item Nos. 00151504232
00151504432
00151504636
00151504836
00151505040
00151505240
00151505444
00151505644
00151505848
00151506048
00151506248
00151506448
0015150 Terminated |
LPH | None listed |
| Aug 14, 2019 | New Standard Device Inc Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A Open, Classified |
HXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.