Zavation Spinal System: FDA 510(k) K153404, Zavation LLC

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK153404	Date21 Apr 2016Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K153404

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K153404
FDA product code: MNH
FDA applicant: Zavation, LLC

Device class: Class II
Regulation: 21 CFR Part 888.3070
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

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

Cites

Synthes Matrix System K120838 31 Jul 2012 FDA record · FDA summary
Zavation Spinal System K112484 22 Nov 2011 FDA record · FDA summary
Optima, Spinal System K024096 12 Mar 2003 FDA record
Synergy Vls Cap Nut Models 2206, 6102 K000236 16 Feb 2000 FDA record
Titanium Moss Miami Spinal System K955348 16 Feb 1996 FDA record

Cited by

Zavation Spinal System K190361 18 Mar 2019 FDA record · FDA summary

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

Devices cleared under K153404

163 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 K153404
		UDI-DI	Size and differences
Zavation 210-1001-35 ZAVATION	210-1001-35	00842166177895	Single use: no	On the market
Zavation 210-1001-40 ZAVATION	210-1001-40	00842166177901	Single use: no	On the market
Zavation 210-1001-60 ZAVATION	210-1001-60	00842166177949	Single use: no	On the market
Zavation 210-1003-5 ZAVATION	210-1003-5	00842166181977	Single use: yes	On the market
Zavation 210-1005-30 ZAVATION	210-1005-30	00842166175181	Single use: no	On the market
Zavation 210-1005-35 ZAVATION	210-1005-35	00842166175198	Single use: no	On the market
Zavation 210-1005-50 ZAVATION	210-1005-50	00842166175228	Single use: no	On the market
Zavation 210-1005-55 ZAVATION	210-1005-55	00842166175235	Single use: no	On the market
Zavation 210-6530 ZAVATION	210-6530	00842166112971	Single use: yes	On the market
Zavation 210-6560 ZAVATION	210-6560	00842166113039	Single use: yes	On the market
Zavation 210-6565 ZAVATION	210-6565	00842166113046	Single use: yes	On the market
Zavation 210-6570 ZAVATION	210-6570	00842166113053	Single use: yes	On the market
Zavation 210-7525 ZAVATION	210-7525	00842166113121	Single use: yes	On the market
Zavation 210-7570 ZAVATION	210-7570	00842166113213	Single use: yes	On the market
Zavation 210-7580 ZAVATION	210-7580	00842166113237	Single use: yes	On the market
Zavation 210-7585 ZAVATION	210-7585	00842166113244	Single use: yes	On the market
Zavation 210-7595 ZAVATION	210-7595	00842166113268	Single use: yes	On the market
Zavation 210-8525 ZAVATION	210-8525	00842166113282	Single use: yes	On the market
Zavation 210-8565 ZAVATION	210-8565	00842166113367	Single use: yes	On the market
Zavation 210-8575 ZAVATION	210-8575	00842166113381	Single use: yes	On the market
Zavation 212-5555 ZAVATION	212-5555	00842166113497	Single use: yes	On the market
Zavation 212-5560 ZAVATION	212-5560	00842166113503	Single use: yes	On the market
Zavation 212-65100 ZAVATION	212-65100	00842166113527	Single use: yes	On the market
Zavation 212-6555 ZAVATION	212-6555	00842166113596	Single use: yes	On the market
Zavation 212-6565 ZAVATION	212-6565	00842166113619	Single use: yes	On the market
Zavation 212-6575 ZAVATION	212-6575	00842166113633	Single use: yes	On the market
Zavation 212-7525 ZAVATION	212-7525	00842166113695	Single use: yes	On the market
Zavation 212-7535 ZAVATION	212-7535	00842166113718	Single use: yes	On the market
Zavation 212-7540 ZAVATION	212-7540	00842166113725	Single use: yes	On the market
Zavation 212-7545 ZAVATION	212-7545	00842166113732	Single use: yes	On the market
Zavation 212-7550 ZAVATION	212-7550	00842166113749	Single use: yes	On the market
Zavation 212-7585 ZAVATION	212-7585	00842166113817	Single use: yes	On the market
Zavation 212-7595 ZAVATION	212-7595	00842166113831	Single use: yes	On the market
Zavation 212-85100 ZAVATION	212-85100	00842166113848	Single use: yes	On the market
Zavation 212-8525 ZAVATION	212-8525	00842166113855	Single use: yes	On the market
Zavation 212-8555 ZAVATION	212-8555	00842166113916	Single use: yes	On the market
Zavation 212-8570 ZAVATION	212-8570	00842166113947	Single use: yes	On the market
Zavation 212-8575 ZAVATION	212-8575	00842166113954	Single use: yes	On the market
Zavation 212-8585 ZAVATION	212-8585	00842166113978	Single use: yes	On the market
Zavation 212-8595 ZAVATION	212-8595	00842166113992	Single use: yes	On the market
Zavation 213-5560 ZAVATION	213-5560	00842166114074	Single use: yes	On the market
Zavation 213-6565 ZAVATION	213-6565	00842166114180	Single use: yes	On the market
Zavation 213-6575 ZAVATION	213-6575	00842166114203	Single use: yes	On the market
Zavation 213-7525 ZAVATION	213-7525	00842166114265	Single use: yes	On the market
Zavation 213-7560 ZAVATION	213-7560	00842166114333	Single use: yes	On the market
Zavation 213-7575 ZAVATION	213-7575	00842166114364	Single use: yes	On the market
Zavation 213-8530 ZAVATION	213-8530	00842166114432	Single use: yes	On the market
Zavation 213-8535 ZAVATION	213-8535	00842166114449	Single use: yes	On the market
Zavation 213-8560 ZAVATION	213-8560	00842166114494	Single use: yes	On the market
Zavation 213-8595 ZAVATION	213-8595	00842166114562	Single use: yes	On the market

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Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).

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Regulatory status

Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K153404

Similar devices

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Zavation Screw 1010-C-075070-S-C

Zavation Screw 1010-C-075075-S-C

Zavation Screw 1010-C-075080-S-C

Zavation Screw 1010-C-075085-S-C