Cleared Traditional

K151268 - SPINAUT-V, SPINAUT-S, SPINAUT-I

K151268 is an FDA 510(k) clearance for SPINAUT-V, manufactured by Imedicom Co., Ltd.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K151268 · Imedicom Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
308d
Days
Class 2
Risk

K151268 is an FDA 510(k) clearance for the SPINAUT-V, SPINAUT-S, SPINAUT-I. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Imedicom Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on March 16, 2016 after a review of 308 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 Imedicom Co., Ltd. devices

FDA 510(k) Submission Details - K151268

510(k) Number K151268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date March 16, 2016
Days to Decision 308 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 122d · This submission: 308d
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 Consultant

LK Consulting Group USA, Inc.
PRISCILLA CHUNG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRX Arthroscope

All 522
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