Relieve

RELIEVE Radiolucent Plate, Open Door, Widemouth, 11mm

Registry build 21.09.26
1manufacturer
28catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code NQW
Manufacturer City Province Registered as Device types
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Relieve
Listed by Globus Medical, Inc., United States
FDA product code NQW
Device type Orthosis, Spine, Plate, Laminoplasty, Metal
Device class Class 2
Regulation 21 CFR 888.3050
Establishment Manufacturer, Exporter
510(k) K080664
Record published 2015-10-01
Record revised 2025-11-20 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Label carries lot or batch number
Sizes Outer diameter 2.2 to 2.6 mm; length 4 to 12 mm; height 5 to 13 mm

Catalogue Numbers

Catalogue numbers for Relieve
Catalogue number Size Status
136.406 Outer Diameter 2.2 mm In distribution
136.405 Length 5 mm In distribution
336.111 Height 11 mm In distribution
136.708 Outer Diameter 2.6 mm In distribution
336.113 Height 13 mm In distribution
136.706 Length 6 mm In distribution
136.704 Outer Diameter 2.6 mm In distribution
136.512 Outer Diameter 2.2 mm In distribution
136.408 Outer Diameter 2.2 mm In distribution
336.307 Height 7 mm In distribution
136.412 Length 12 mm In distribution
136.510 Outer Diameter 2.2 mm In distribution
336.305 Height 5 mm In distribution
336.309 Height 9 mm In distribution
336.311 Height 11 mm In distribution
136.410 Outer Diameter 2.2 mm In distribution
136.705 Length 5 mm In distribution
136.710 Length 10 mm In distribution
336.313 Height 13 mm In distribution
136.404 Length 4 mm In distribution
136.504 Outer Diameter 2.2 mm In distribution
136.506 Length 6 mm In distribution
136.505 Outer Diameter 2.2 mm In distribution
336.105 Height 5 mm In distribution
136.508 Outer Diameter 2.2 mm In distribution
336.107 Height 7 mm In distribution
136.712 Outer Diameter 2.6 mm In distribution
336.109 Height 9 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Xspan Laminoplasty Fixation System Xtant Medical Holdings, Inc. 265
Hinged Laminoplasty Life Spine 129
Laminoplasty Seaspine Orthopedics Corporation 104
Release® Laminoplasty Fixation System Pioneer Surgical Technology, Inc. 88
Gallery Laminoplasty System Biomet Spine 80
Canopy Globus Medical, Inc. 65
Centerpiece™ Plate Fixation System Medtronic Sofamor Danek, Inc. 61
Blackbird HLS Choice Spine, LP 55
Prowess Laminoplasty System Curiteva, Inc. 42
Gallery Laminoplasty Fixation System Highridge Medical, LLC 40
Leverage Nuvasive, Inc. 38
Camber Nuvasive, Inc. 27

Showing 12 of 19. All products under Orthosis, Spine, Plate, Laminoplasty, Metal

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K171413 2017-07-14
K121732 2012-10-31
K080664 2008-07-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer