Product code MNH: 510(k) clearances and predicates
Product code MNH covers Reliance Spinal Screw System. FDA lists 309 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
309 clearances on file under product code MNH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest MNH clearances in the FDA index, with applicant and decision date:
- K162066, Reliance Spinal Screw System, applicant Reliance Medical Systems, LLC, decided 2016-12-02. FDA record
- K162801, CastleLoc Spinal Fixation System, applicant L&K BIOMED Co., Ltd., decided 2016-11-03. FDA record
- K162143, FixxSure® X-Link, applicant Innovasis, Inc., decided 2016-09-23. FDA record
- K161151, Spinal fixation system, applicant Canwell Medical Co., Ltd., decided 2016-09-21. FDA record
- K162189, ANAX 5.5 Spinal System, applicant U&I Corporation, decided 2016-08-30. FDA record
- K151362, HC Spinal System, applicant Hung Chun Bio-S Co., Ltd., decided 2016-05-05. FDA record
- K153404, Zavation Spinal System, applicant Zavation, LLC, decided 2016-04-21. FDA record
- K160020, Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System, applicant Captiva Spine, decided 2016-03-02. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include CastleLoc Spinal Fixation System, FixxSure® X-Link. Watch new MNH clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MNH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MNH clearances include Reliance Spinal Screw System.
How many 510(k) clearances use product code MNH?
309 at the time this page was generated, from openFDA records.
How do I find a predicate device under MNH?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MNH clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for MNH, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free MNH brief
Tell us where to send it. No card required.
You are on the list.
We will email your free MNH brief shortly. MNH is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.