Cleared Special

K232822 - Peridot-TD Spacer system (The Peridot-T...

K232822 is an FDA 510(k) clearance for Peridot-TD Spacer system (The Peridot-T..., manufactured by Gbs Commonwealth Co., Ltd.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 30-day FDA review.

K232822 · Gbs Commonwealth Co., Ltd. · Orthopedic device
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Oct 2023
Decision
30d
Days
Class 2
Risk

K232822 is an FDA 510(k) clearance for the Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), .... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Gbs Commonwealth Co., Ltd. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on October 13, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gbs Commonwealth Co., Ltd. devices

FDA 510(k) Submission Details - K232822

510(k) Number K232822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2023
Decision Date October 13, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 242
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K232822.
ClariVy™ Cervical IBF System
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Acro Composites Interbody System
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HAtetracell™-C Titanium Cervical IBF System
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VariLift®-C Interbody Fusion System
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neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
K222988 · Ht Medical D.B.A. Xenix Medical · Sep 2023
ZSFab Cervical Interbody System
K232150 · Zsfab, Inc. · Aug 2023