Cleared Traditional

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) (K230708) - FDA 510(k) Clearance

Also marketed or referenced as:
Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230708 · Gbs Commonwealth Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
69d
Days
Class 2
Risk

K230708 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 May 22, 2023 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gbs Commonwealth Co., Ltd. devices

Submission Details

510(k) Number K230708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2023
Decision Date May 22, 2023
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K230708.
Integral Titanium Cervical Interbody
K222015 · Nvision Biomedical Technologies, Inc. · Jul 2023
F3D Interbody System
K230329 · Corelink, LLC · Jun 2023
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
K230936 · Nanovis, LLC · Jun 2023
Ventana™ C Spinal System
K222833 · Spinal Elements, Inc. · May 2023
ClariVy™ Cervical IBF System
K230414 · Vy Spine, LLC · May 2023
INTEGRATE -C Interbody Fusion System
K222004 · Happe Spine · Apr 2023