DeviceClearance

CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC— 510(k) K133455

Substantially Equivalent

Pioneer Surgical Technology, Inc.

FDA 510(k) clearance K133455 for CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC, Substantially Equivalent on 2014-03-27. Applicant: Pioneer Surgical Technology, Inc.. Device class: 2.

Clearance details

Applicant
Pioneer Surgical Technology, Inc.
Product code
Code MAX
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marquette, MI, US
Download summary PDFView on FDA.gov ↗

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More clearances from Pioneer Surgical Technology, Inc.

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Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K133455

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133455.

Data sourced from openFDA. This site is unofficial and independent of the FDA.