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OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. vs Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.: FDAPulse comparison
OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.'s review days of 260 is 1.0x Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.'s 253 (82nd percentile). OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. is dated 2026-09-15; Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. 2026-09-24.
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 OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. compare to Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.?
| Field | OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K254214 | K260114 |
| Device | OOOPDS | Align® Cover and Pad Guidance Tool |
| Applicant | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | CIVCO Medical Instruments Co., Inc. |
| Specialty / panel | Radiology | Radiology |
| Product code | LLZ | ITX |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-12-29 | 2026-01-14 |
| Decision date | 2026-09-15 | 2026-09-24 |
| Review time (days) | 260 | 253 |
| Third-party review | No | No |
| Applicant location | Taichung, TW | Coralville, IA, US |
| amount percentile | 82nd | 80th |
| Predicate Speed & CAPA Advisory Opportunity Score | 55/100 | 61/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.
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