Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
Tempo Plating System (K263407): 510(k) cleared for Pace Surgical (Pennsylvania): 510(k) cleared for Pace Surgical. Its amount of 28 is below the median of 138 (6th percentile). Dated 12 days ago, it is in the active follow-up window. Score 47/100. 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: 28 · 6th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263407 |
| Device | Tempo Plating System |
| Applicant | Pace Surgical |
| Specialty / panel | Orthopedic |
| Product code | HRS |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-25 |
| Decision date | 2026-10-23 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Malvern, PA, US |
| amount percentile | 6th of 414 (median 138, 0.2x median) |
| Peer records CSV (19 PA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-10-23
- 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: Tempo Plating System (K263407): 510(k) cleared for Pace Surgical and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Tempo Plating System (K263407): 510(k) cleared for Pace Surgical's amount: 6th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
47 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 12 days ago.
What is the FDAPulse record for Tempo Plating System (K263407): 510(k) cleared for Pace Surgical in Pennsylvania?
Tempo Plating System (K263407) by Pace Surgical was cleared on 2026-10-23 after 28 days of review.
How does Tempo Plating System (K263407): 510(k) cleared for Pace Surgical compare to other Pennsylvania FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
Tempo Plating System (K263407) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Tempo Plating System (K263407) | PA | 2026-10-23 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
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