Foundation 3D Interbody: FDA 510(k) K162496, Corelink LLC

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK162496	Date4 May 2017Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K162496

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K162496
FDA product code: ODP
FDA applicant: Corelink, LLC

Device class: Class II
Regulation: 21 CFR Part 888.3080
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

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System K153250 16 Mar 2016 FDA record · FDA summary
Amendia Interbody Fusion Devices K151322 10 Sep 2015 FDA record · FDA summary
Foundation Interbody Devices K150847 13 Aug 2015 FDA record · FDA summary
Foundation Cage K073440 24 Apr 2008 FDA record

Cited by

Kodiak Lumbar Spacer System K230851 26 May 2023 FDA record · FDA summary
restor3d TiDAL Lumbar Interbody Fusion Device K220523 17 Jun 2022 FDA record · FDA summary
ShurFit Lumbar Interbody System K212075 8 Dec 2021 FDA record · FDA summary
Tailored-C Cervical Interbody Fusion System K200458 28 Dec 2020 FDA record · FDA summary
GAIA Lumbar Interbody Fusion Device (LIFD) Family K201939 8 Oct 2020 FDA record · FDA summary
TxTi IBF System K183064 28 Jun 2019 FDA record · FDA summary
CoreLink F3D™ Lateral System K183239 19 Dec 2018 FDA record · FDA summary
CoreLink® M3™ Stand-Alone Anterior Lumbar System K180814 10 Aug 2018 FDA record · FDA summary
Corelink Foundation 3D Anterior Lumbar System K180556 27 Jul 2018 FDA record · FDA summary

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

Devices cleared under K162496

213 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 K162496
		UDI-DI	Size and differences
ZAVATION INSTRUMENT TRAY 14T00924 ZAVATION	14T00924	00197157068417	—	On the market
ZAVATION INSTRUMENT TRAY 14T00926 ZAVATION	14T00926	00197157068431	—	On the market
ZAVATION SIZER 29-141200-08 ZAVATION	29-141200-08	00197157078287	—	On the market
ZAVATION SIZER 29-141200-10 ZAVATION	29-141200-10	00197157078300	—	On the market
ZAVATION SIZER 29-141210-09 ZAVATION	29-141210-09	00197157078218	—	On the market
ZAVATION SIZER 29-151300-09 ZAVATION	29-151300-09	00197157078539	—	On the market
ZAVATION SIZER 29-151300-10 ZAVATION	29-151300-10	00197157078546	—	On the market
ZAVATION SIZER 29-151300-11 ZAVATION	29-151300-11	00197157078553	—	On the market
ZAVATION SIZER 29-151306-05 ZAVATION	29-151306-05	00197157078331	—	On the market
ZAVATION SIZER 29-151306-07 ZAVATION	29-151306-07	00197157078355	—	On the market
ZAVATION SIZER 29-151306-10 ZAVATION	29-151306-10	00197157078386	—	On the market
ZAVATION SIZER 29-151306-12 ZAVATION	29-151306-12	00197157078409	—	On the market
ZAVATION SIZER 29-151310-05 ZAVATION	29-151310-05	00197157078416	—	On the market
ZAVATION TRIAL 02P00083 ZAVATION	02P00083	00197157056636	—	On the market
ZAVATION TRIAL 02P00085 ZAVATION	02P00085	00197157056650	—	On the market
ZAVATION TRIAL 02P00088 ZAVATION	02P00088	00197157056681	—	On the market
ZAVATION TRIAL 02P00092 ZAVATION	02P00092	00197157056728	—	On the market
ZAVATION TRIAL 02P00095 ZAVATION	02P00095	00197157056759	—	On the market
ZAVATION TRIAL 02P00096 ZAVATION	02P00096	00197157056766	—	On the market
ZAVATION TRIAL 02P00099 ZAVATION	02P00099	00197157056797	—	On the market
ZAVATION TRIAL 02P01232 ZAVATION	02P01232	00197157056995	—	On the market
ZAVATION TRIAL 02P01349 ZAVATION	02P01349	00197157057046	—	On the market
ZAVATION TRIAL 02P02911 ZAVATION	02P02911	00197157057176	—	On the market
ZAVATION TRIAL 02P02913 ZAVATION	02P02913	00197157057190	—	On the market
ZAVATION TRIAL 02P02921 ZAVATION	02P02921	00197157057275	—	On the market
ZAVATION TRIAL 02T00942 ZAVATION	02T00942	00197157077174	—	On the market
ZAVATION TRIAL 02T00951 ZAVATION	02T00951	00197157077181	—	On the market
ZAVATION TRIAL 02T00961 ZAVATION	02T00961	00197157077198	—	On the market
ZAVATION TRIAL 02T00981 ZAVATION	02T00981	00197157077228	—	On the market
ZAVATION TRIAL 02T00991 ZAVATION	02T00991	00197157077327	—	On the market
ZAVATION TRIAL 02T00994 ZAVATION	02T00994	00197157077358	—	On the market
ZAVATION TRIAL 02T00995 ZAVATION	02T00995	00197157077365	—	On the market
ZAVATION TRIAL 02T01000 ZAVATION	02T01000	00197157077419	—	On the market
ZAVATION TRIAL 02T01005 ZAVATION	02T01005	00197157077464	—	On the market
ZAVATION TRIAL 02T01010 ZAVATION	02T01010	00197157077518	—	On the market
ZAVATION TRIAL 02T01017 ZAVATION	02T01017	00197157077587	—	On the market
ZAVATION TRIAL 02T01020 ZAVATION	02T01020	00197157077617	—	On the market
ZAVATION TRIAL 02T01021 ZAVATION	02T01021	00197157077624	—	On the market
ZAVATION TRIAL 02T01025 ZAVATION	02T01025	00197157077662	—	On the market
ZAVATION TRIAL 02T01029 ZAVATION	02T01029	00197157077709	—	On the market
ZAVATION TRIAL 02T01032 ZAVATION	02T01032	00197157077730	—	On the market
ZAVATION TRIAL 02T01035 ZAVATION	02T01035	00197157077761	—	On the market
ZAVATION TRIAL 02T01040 ZAVATION	02T01040	00197157077815	—	On the market
ZAVATION TRIAL 8718-212 ZAVATION	8718-212	00197157077938	—	On the market
ZAVATION TRIAL 8718-806 ZAVATION	8718-806	00197157077952	—	On the market
ZAVATION TRIAL 8718-812 ZAVATION	8718-812	00197157077983	—	On the market
ZAVATION TRIAL 8722-208 ZAVATION	8722-208	00197157078003	—	On the market
ZAVATION TRIAL 8722-210 ZAVATION	8722-210	00197157078010	—	On the market
ZAVATION TRIAL 8722-212 ZAVATION	8722-212	00197157078027	—	On the market
ZAVATION TRIAL 8722-806 ZAVATION	8722-806	00197157078041	—	On the market

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Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

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Regulatory status

Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K162496

Similar devices

Other devices from Corelink LLC

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ANODYNE Plate System 20140-16

TIGER Spine System 55605-60