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prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC vs Tempo Plating System (K263407): 510(k) cleared for Pace Surgical: FDAPulse comparison
prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC's review days of 28 is 1.0x Tempo Plating System (K263407): 510(k) cleared for Pace Surgical's 28 (6th percentile). prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC is dated 2026-10-07; Tempo Plating System (K263407): 510(k) cleared for Pace Surgical 2026-10-23.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC compare to Tempo Plating System (K263407): 510(k) cleared for Pace Surgical?
| Field | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC | Tempo Plating System (K263407): 510(k) cleared for Pace Surgical |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K263159 | K263407 |
| Device | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments | Tempo Plating System |
| Applicant | Centinel Spine, LLC | Pace Surgical |
| Specialty / panel | Orthopedic | Orthopedic |
| Product code | QLQ | HRS |
| Device class | 2 | 2 |
| Clearance type | Special | Special |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-09-09 | 2026-09-25 |
| Decision date | 2026-10-07 | 2026-10-23 |
| Review time (days) | 28 | 28 |
| Third-party review | No | No |
| Applicant location | West Chester, PA, US | Malvern, PA, US |
| amount percentile | 6th | 6th |
| Predicate Speed & CAPA Advisory Opportunity Score | 41/100 | 47/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC · Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
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