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=K263269

Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.

Q: How to monitor Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd. and peer orthopedic records

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Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.: 510(k) cleared for Tdm Co., Ltd. Its amount of 27 is below the median of 138 (3rd percentile). Dated 21 days ago, it is in the active follow-up window. Score 41/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 27 · 3th percentile of 414 FDAPulse records · 0.2x 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	K263269
Device	Park's Pectus System
Applicant	Tdm Co., Ltd.
Specialty / panel	Orthopedic
Product code	HRS
Device class	2
Clearance type	Special
Decision	Substantially Equivalent
Received	2026-09-18
Decision date	2026-10-15
Review time (days)	27
Third-party review	No
Applicant location	Gwangju, KR
amount percentile	3th of 414 (median 138, 0.2x median)
Peer records CSV (32 KR records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-15
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd. and 32 KR peers

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

KR FDAPulse records like this one: 32
Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.'s amount: 3rd 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)

41 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 27-day review: this device is a strong predicate for similar products.
Special 510(k): a modification of an existing device.
Posted 21 days ago.

What is the FDAPulse record for Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.?

Park's Pectus System (K263269) by Tdm Co., Ltd. was cleared on 2026-10-15 after 27 days of review.

How does Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd. compare to other FDAPulse records?

Its amount of 27 is below the median (3th percentile); smaller records often move faster and face less competition. It is 21 days old, still within a typical 45-day follow-up window.

Park's Pectus System (K263269) vs. top 2 peers

Organization	Location	Record date
Park's Pectus System (K263269)	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 Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd. and peer orthopedic records

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