EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies
EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies (Texas): 510(k) cleared for Nvision Biomedical Technologies. Its amount of 88 is below the median of 138 (28th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 35/100. As of 2026-11-04, 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: 88 · 28th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262098 |
| Device | EnHAnce PEEK Bunion System |
| Applicant | Nvision Biomedical Technologies |
| Specialty / panel | Orthopedic |
| Product code | HRS |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-06-22 |
| Decision date | 2026-09-18 |
| Review time (days) | 88 |
| Third-party review | No |
| Applicant location | San Antonio, TX, US |
| amount percentile | 28th of 414 (median 138, 0.6x 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: 2026-09-18
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (TX first): MyoVista wavECG (DG-200-B15-003) (K260005) · Small Diameter Core Wire (CMAN-000-00); Small Diameter Core · Kinetic Software Library (K260640) · SmartRead(TM) Medical Device Identifier (4100) (DEN260007) · DASH Flu A/B Test (K261347) · Browse all by state and category →
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: EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies and 12 Texas peers
- Texas FDAPulse records like this one: 12
- EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies's amount: 28th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 88-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
What is the FDAPulse record for EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies in Texas?
EnHAnce PEEK Bunion System (K262098) by Nvision Biomedical Technologies was cleared on 2026-09-18 after 88 days of review.
How does EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies compare to other Texas FDAPulse records?
Its amount of 88 is below the median (28th percentile); smaller records often move faster and face less competition. It is 48 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 35/100 is modest; treat it as background rather than a priority.
EnHAnce PEEK Bunion System (K262098) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| EnHAnce PEEK Bunion System (K262098) | TX | 2026-09-18 |
| 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 |
Related records
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- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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