Cleared Traditional

K082841 - SPINAL FORAMINOSCOPE

K082841 is an FDA 510(k) clearance for SPINAL FORAMINOSCOPE, manufactured by Blazejewski Medi-Tech GmbH. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K082841 · Blazejewski Medi-Tech GmbH · Orthopedic device
Download Printable Device Report (PDF)
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Sep 2009
Decision
348d
Days
Class 2
Risk

K082841 is an FDA 510(k) clearance for the SPINAL FORAMINOSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Blazejewski Medi-Tech GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on September 9, 2009 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Blazejewski Medi-Tech GmbH devices

FDA 510(k) Submission Details - K082841

510(k) Number K082841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2008
Decision Date September 09, 2009
Days to Decision 348 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 122d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 473
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K082841.
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