Spinous Process Plate System: FDA 510(k) K073278

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK073278	Date28 Mar 2008Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K073278

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K073278
FDA product code: KWP

Device class: Class II
Regulation: 21 CFR Part 888.3050
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

coflex-IF K153302 8 Sep 2016 FDA record · FDA summary
Reliance Interspinous Plate System K142217 2 Apr 2015 FDA record · FDA summary
Interspinous Plate System K142378 18 Dec 2014 FDA record · FDA summary
Romeo 2 Pad Posterior Axial Device K141508 21 Aug 2014 FDA record · FDA summary
Interbridge Interspinous Posterior Fixation System K133363 7 Mar 2014 FDA record · FDA summary
Affix(R) Next Gen Spinous Process Plate System K133052 20 Dec 2013 FDA record · FDA summary
Zip Mis Interspinous Fusion System K133091 27 Nov 2013 FDA record · FDA summary
Affix Ii Spinous Process Plate System K132411 20 Nov 2013 FDA record · FDA summary
Integra Interspinous Process System K121924 4 Sep 2013 FDA record · FDA summary
Affix Spinous Process Plate System K131238 2 Jul 2013 FDA record · FDA summary

7 more clearances cite this device.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K073278

12 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K073278
		UDI-DI	Size and differences
Affix 7571045 NuVasive, LLC	7571045	00887517058676	Single use: yes	On the market
Affix 7571055 NuVasive, LLC	7571055	00887517058683	Single use: yes	On the market
Affix 7571135 NuVasive, LLC	7571135	00887517059161	Single use: no	On the market
Affix 7571140 NuVasive, LLC	7571140	00887517059178	Single use: no	On the market
Affix 7571145 NuVasive, LLC	7571145	00887517059185	Single use: no	On the market
Affix 7577025 NuVasive, LLC	7577025	00887517062338	Single use: no	On the market
Affix 7577035 NuVasive, LLC	7577035	00887517062345	Single use: no	On the market
Affix 7577045 NuVasive, LLC	7577045	00887517062352	Single use: no	On the market
Affix 7577055 NuVasive, LLC	7577055	00887517062369	Single use: no	On the market
Affix 7579035 NuVasive, LLC	7579035	00887517063670	Single use: yes	On the market
Affix 7579040 NuVasive, LLC	7579040	00887517063687	Single use: yes	On the market
Affix 7579045 NuVasive, LLC	7579045	00887517063694	Single use: yes	On the market

Similar devices

Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).

Other devices from Nuvasive, Inc.

Pulse

Class I
NuVasive CoRoent System

Class II
NuVasive CoRoent Titanium System

Class II
Modification to Nuvasive Neurovision Jjb System

Class II

See all devices from Nuvasive, Inc. →

Regulatory status

Coverage

Specification

Related clearances

Cited by

Devices cleared under K073278

Similar devices

Other devices from Nuvasive, Inc.

Pulse

NuVasive CoRoent System

NuVasive CoRoent Titanium System

Modification to Nuvasive Neurovision Jjb System