NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.
NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.: 510(k) cleared for Medyssey Co., Ltd. Its amount of 60 is below the median of 138 (18th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 60 · 18th percentile of 414 FDAPulse records · 0.4x 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 | K262726 |
| Device | NeckTune SA Cervical Cage |
| Applicant | Medyssey Co., Ltd. |
| Specialty / panel | Orthopedic |
| Product code | OVE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-31 |
| Decision date | 2026-09-29 |
| Review time (days) | 60 |
| Third-party review | No |
| Applicant location | Jecheon-Si, KR |
| amount percentile | 18th of 414 (median 138, 0.4x median) |
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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: 2026-09-29
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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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
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Peer benchmark and outreach value: NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd. and 32 KR peers
- KR FDAPulse records like this one: 32
- NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.'s amount: 18th percentile of 414 records
- Timing: Low: older than 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 60-day review: this device is a strong predicate for similar products.
- Posted 36 days ago.
What is the FDAPulse record for NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.?
NeckTune SA Cervical Cage (K262726) by Medyssey Co., Ltd. was cleared on 2026-09-29 after 60 days of review.
How does NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd. compare to other FDAPulse records?
Its amount of 60 is below the median (18th percentile); smaller records often move faster and face less competition. It is 36 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.
NeckTune SA Cervical Cage (K262726) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| NeckTune SA Cervical Cage (K262726) | KR | 2026-09-29 |
| The VEGA Cervical Screw System (K254260) | KR | 2026-09-17 |
| AnyPlus II Spinal Fixation System (K261217) | KR | 2026-10-02 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
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