Cleared Traditional

K070351 - SPACE 360 DELIVERY SYSTEM

K070351 is an FDA 510(k) clearance for SPACE 360 DELIVERY SYSTEM, manufactured by Dfine, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K070351 · Dfine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
143d
Days
Class 2
Risk

K070351 is an FDA 510(k) clearance for the SPACE 360 DELIVERY SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Dfine, Inc. (Cupertino, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K070351

510(k) Number K070351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2007
Decision Date June 29, 2007
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K070351.
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K071927 · Depuy Spine, A Johnson & Johnson Company · Nov 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133 · Cardinal Health, Inc. · Nov 2007
MODIFICATION TO SPACE CPSXL BONE CEMENT
K072496 · Dfine, Inc. · Oct 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · Medtronic Sofamor Danek · May 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · Medtronic Sofamor Danek · Mar 2007
VSPSPN
K063438 · Tecres S.P.A. · Jan 2007
K070351 · SPACE 360 DELIVERY SYSTEM
Download PDF FDA Summary Dfine, Inc.