Cleared Traditional

K083342 - ORBITAL RECONSTRUCTIVE IMPLANT II

K083342 is an FDA 510(k) clearance for ORBITAL RECONSTRUCTIVE IMPLANT II, manufactured by Evera Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K083342 · Evera Medical, Inc. · Ophthalmic device
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Mar 2009
Decision
120d
Days
Class 2
Risk

K083342 is an FDA 510(k) clearance for the ORBITAL RECONSTRUCTIVE IMPLANT II. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Evera Medical, Inc. (Foster City, US). The FDA issued a Cleared decision on March 12, 2009 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - the FDA ophthalmic device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Evera Medical, Inc. devices

FDA 510(k) Submission Details - K083342

510(k) Number K083342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date March 12, 2009
Days to Decision 120 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HPZ Device Classification - Class 2, Special Controls

Product Code HPZ Implant, Eye Sphere
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HPZ Implant, Eye Sphere

All 12
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K083342.
EZYPOR
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K010902 · Porex Surgical, Inc. · Jun 2001
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K982562 · Integrated Orbital Implants, Inc. · Dec 1998