ELSA Spacers intervertebral fusion device

Regulatory status

as of registry sync 11 Nov 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK161379	Date29 Sep 2016Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K161379

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K161379
FDA product code: OVD

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

PIVOX(tm) Oblique Lateral Spinal System K152277 13 Nov 2015 FDA record · FDA summary
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti K150643 8 Jun 2015 FDA record · FDA summary
NuVasive CoRoent System K141665 13 Mar 2015 FDA record · FDA summary
Coroent Xl-F System K140479 28 Jul 2014 FDA record · FDA summary
Caliber Spacers K123231 18 Jan 2013 FDA record · FDA summary
Intercontinental Plate-Spacer K103382 20 May 2011 FDA record · FDA summary
Caliber Spacer K102293 5 Jan 2011 FDA record · FDA summary

Cited by

ExcelsiusGPS™ Instruments K250599 5 Nov 2025 FDA record · FDA summary
COSINE™ Spacer K234035 6 Sep 2024 FDA record · FDA summary
ADIRA™ Lateral Plate System K233735 25 Jan 2024 FDA record · FDA summary
Peridot-EX Expandable Intervertebral Body Fusion System K232292 7 Nov 2023 FDA record · FDA summary
Calibrate LTX Interbody System K222455 18 Nov 2022 FDA record · FDA summary
ProLift Lateral HELO Fixated K210061 30 Apr 2021 FDA record · FDA summary
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers K203278 2 Feb 2021 FDA record · FDA summary
ProLift Lateral Fixated K200338 17 Apr 2020 FDA record · FDA summary
Peridot Intervertebral body fusion System K192026 26 Nov 2019 FDA record · FDA summary
ExcelsiusGPS Spine 1.1 Interbody Module K191100 24 Jul 2019 FDA record · FDA summary

2 more clearances cite this device.

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

Overview

AI-generated summary, 11 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ELSA Spacers are an intervertebral fusion device with integrated fixation, specifically for the lumbar region. ELSA Spacers were cleared under 510(k) K161379, which was decided on 2016-09-29, and classified as Class II under FDA regulation number 888.3080 with product code OVD.

Devices cleared under K161379

30 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 K161379
		UDI-DI	Size and differences
ELSA 1122.0040 GLOBUS MEDICAL, INC.	1122.0040	00889095257922	—	On the market
ELSA 1122.0045 GLOBUS MEDICAL, INC.	1122.0045	00889095257939	—	On the market
ELSA 1122.0050 GLOBUS MEDICAL, INC.	1122.0050	00889095257946	—	On the market
ELSA 1122.0055 GLOBUS MEDICAL, INC.	1122.0055	00889095257953	—	On the market
ELSA 1122.0060 GLOBUS MEDICAL, INC.	1122.0060	00889095257960	—	On the market
ELSA 1122.0065 GLOBUS MEDICAL, INC.	1122.0065	00889095257977	—	On the market
ELSA 1122.0140 GLOBUS MEDICAL, INC.	1122.0140	00889095257991	—	On the market
ELSA 1122.0145 GLOBUS MEDICAL, INC.	1122.0145	00889095258004	—	On the market
ELSA 1122.0150 GLOBUS MEDICAL, INC.	1122.0150	00889095258011	—	On the market
ELSA 1122.0155 GLOBUS MEDICAL, INC.	1122.0155	00889095258028	—	On the market
ELSA 1122.0160 GLOBUS MEDICAL, INC.	1122.0160	00889095258035	—	On the market
ELSA 1122.0165 GLOBUS MEDICAL, INC.	1122.0165	00889095258042	—	On the market
ELSA 1122.0440 GLOBUS MEDICAL, INC.	1122.0440	00889095258066	—	On the market
ELSA 1122.0445 GLOBUS MEDICAL, INC.	1122.0445	00889095258073	—	On the market
ELSA 1122.0450 GLOBUS MEDICAL, INC.	1122.0450	00889095258080	—	On the market
ELSA 1122.0455 GLOBUS MEDICAL, INC.	1122.0455	00889095258097	—	On the market
ELSA 1122.0460 GLOBUS MEDICAL, INC.	1122.0460	00889095258103	—	On the market
ELSA 1122.0465 GLOBUS MEDICAL, INC.	1122.0465	00889095258110	—	On the market
ELSA 1122.1040 GLOBUS MEDICAL, INC.	1122.1040	00889095334401	—	On the market
ELSA 1122.1045 GLOBUS MEDICAL, INC.	1122.1045	00889095334418	—	On the market
ELSA 1122.1050 GLOBUS MEDICAL, INC.	1122.1050	00889095334425	—	On the market
ELSA 1122.1055 GLOBUS MEDICAL, INC.	1122.1055	00889095334432	—	On the market
ELSA 1122.1060 GLOBUS MEDICAL, INC.	1122.1060	00889095334449	—	On the market
ELSA 1122.1065 GLOBUS MEDICAL, INC.	1122.1065	00889095334456	—	On the market
ELSA 1122.2040 GLOBUS MEDICAL, INC.	1122.2040	00889095334470	—	On the market
ELSA 1122.2045 GLOBUS MEDICAL, INC.	1122.2045	00889095334487	—	On the market
ELSA 1122.2050 GLOBUS MEDICAL, INC.	1122.2050	00889095334494	—	On the market
ELSA 1122.2055 GLOBUS MEDICAL, INC.	1122.2055	00889095334500	—	On the market
ELSA 1122.2060 GLOBUS MEDICAL, INC.	1122.2060	00889095334517	—	On the market
ELSA 1122.2065 GLOBUS MEDICAL, INC.	1122.2065	00889095334524	—	On the market

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Other devices filed under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

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ELSA Spacers

Regulatory status

Coverage

Specification

Overview

Devices cleared under K161379

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Overview

Devices cleared under K161379

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