Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262522

Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.

Q: How to monitor Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd. and peer orthopedic records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.: 510(k) cleared for Medyssey Co, Ltd. Its amount of 85 is below the median of 138 (25th percentile). Dated 20 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 85 · 25th percentile of 414 FDAPulse records · 0.6x the median

Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K262522
Device	Odys-SI Screw
Applicant	Medyssey Co, Ltd.
Specialty / panel	Orthopedic
Product code	OUR
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-07-22
Decision date	2026-10-15
Review time (days)	85
Third-party review	No
Applicant location	Jecheon-Si, KR
amount percentile	25th of 414 (median 138, 0.6x median)
Peer records CSV (32 KR records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

View the official record

Markdown version

Watch Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.

Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.

Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.

Unlock Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co + all 32 KR records (CSV)

Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL

Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-15
Data refreshed: 2026-11-03
Refunds on request within 14 days

Search all KR records free →

Top FDAPulse records (KR first): cCeLL405 (K254030) · ECG Analysis Software (AiTiALVSD) (K254302) · REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210) · S-Patch CardioAI (K254255) · PicoreMax (PicoreMax) (K254199) · Browse all by state and category →

LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

Is this your business? Add a "Listed on Zalwin" badge to your site

Paste this snippet into your website. It links to this public record; nothing is tracked on your site.

<a href="https://zalwin.com/report/fdapulse/odys-si-screw-k262522-kr--k262522" rel="noopener"><img src="https://zalwin.com/badge/listed.svg" alt="Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd. on Zalwin public records" width="150" height="28"></a>

Peer benchmark and outreach value: Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd. and 32 KR peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

KR FDAPulse records like this one: 32
Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.'s amount: 25th percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

36 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 85-day review: this device is a strong predicate for similar products.
Posted 20 days ago.

What is the FDAPulse record for Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.?

Odys-SI Screw (K262522) by Medyssey Co, Ltd. was cleared on 2026-10-15 after 85 days of review.

How does Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd. compare to other FDAPulse records?

Its amount of 85 is below the median (25th percentile); smaller records often move faster and face less competition. It is 20 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.

Odys-SI Screw (K262522) vs. top 2 peers

Organization	Location	Record date
Odys-SI Screw (K262522)	KR	2026-10-15
The VEGA Cervical Screw System (K254260)	KR	2026-09-17
AnyPlus II Spinal Fixation System (K261217)	KR	2026-10-02

How to monitor Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd. and peer orthopedic records

Get new FDAPulse records like Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd. by email (free, weekly)

We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.

Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.

See this week's digest

Get clearances and recalls like this every day

FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.

See plans

✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

Often used together

Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.