Facet Fixx

510(k) K131417

Facet Fixx is a device classified as Unclassified made by Nexxt Spine, LLC, cleared under FDA 510(k) K131417 on 12 Jul 2013, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K131417↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK131417	Date12 Jul 2013Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K131417

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K131417
FDA product code: MRW

Device class: U
Advisory committee: Unknown
FDA decision: SESE Substantially Equivalent

Devices cleared under K131417

91 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 K131417
		UDI-DI	Size and differences
Facet Fixx™ Facet Screw System 14-09-4520 NEXXT SPINE LLC	14-09-4520	00889929019689	Outer Diameter 4.5 mm; Length 20 mm Prescription: yes; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-09-4525 NEXXT SPINE LLC	14-09-4525	00889929019696	Length 25 mm; Outer Diameter 4.5 mm Prescription: yes; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-09-4530 NEXXT SPINE LLC	14-09-4530	00889929019702	Outer Diameter 4.5 mm; Length 30 mm Prescription: yes; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-09-4540 NEXXT SPINE LLC	14-09-4540	00889929019719	Length 40 mm; Outer Diameter 4.5 mm Prescription: yes; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-09-5040 NEXXT SPINE LLC	14-09-5040	00889929019726	Outer Diameter 5.0 mm; Length 40 mm Prescription: yes; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-09-6040 NEXXT SPINE LLC	14-09-6040	00889929019740	Outer Diameter 6.0 mm; Length 40 mm Prescription: yes; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-4520 NEXXT SPINE LLC	14-10-4520	00889929000670	Length 20 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-4525 NEXXT SPINE LLC	14-10-4525	00889929000687	Length 25 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-4528 NEXXT SPINE LLC	14-10-4528	00889929000694	Length 27.5 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-4530 NEXXT SPINE LLC	14-10-4530	00889929000700	Length 30 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-4540 NEXXT SPINE LLC	14-10-4540	00889929000731	Length 40 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-4545 NEXXT SPINE LLC	14-10-4545	00889929000755	Length 45 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-4548 NEXXT SPINE LLC	14-10-4548	00889929000762	Length 47.5 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5020 NEXXT SPINE LLC	14-10-5020	00889929000786	Length 20 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5025 NEXXT SPINE LLC	14-10-5025	00889929000793	Length 25 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5030 NEXXT SPINE LLC	14-10-5030	00889929000816	Length 30 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5033 NEXXT SPINE LLC	14-10-5033	00889929000823	Length 32.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5035 NEXXT SPINE LLC	14-10-5035	00889929000830	Length 35 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5040 NEXXT SPINE LLC	14-10-5040	00889929000847	Length 40 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5043 NEXXT SPINE LLC	14-10-5043	00889929000854	Length 42.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-5048 NEXXT SPINE LLC	14-10-5048	00889929000878	Length 47.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-10-6040 NEXXT SPINE LLC	14-10-6040	00889929024928	Length 40 mm; Outer Diameter 6.0 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-4528 NEXXT SPINE LLC	14-11-4528	00889929000939	Length 27.5 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-4540 NEXXT SPINE LLC	14-11-4540	00889929000977	Length 40 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-4545 NEXXT SPINE LLC	14-11-4545	00889929000991	Length 45 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-4550 NEXXT SPINE LLC	14-11-4550	00889929001011	Length 50 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-5028 NEXXT SPINE LLC	14-11-5028	00889929001042	Length 27.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-5033 NEXXT SPINE LLC	14-11-5033	00889929001066	Length 32.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-5035 NEXXT SPINE LLC	14-11-5035	00889929001073	Length 35 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-5048 NEXXT SPINE LLC	14-11-5048	00889929001110	Length 47.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-11-5540 NEXXT SPINE LLC	14-11-5540	00889929024935	Outer Diameter 5.5 mm; Length 40 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-4525 NEXXT SPINE LLC	14-12-4525	00889929001165	Length 25 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-4528 NEXXT SPINE LLC	14-12-4528	00889929001172	Length 27.5 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-4530 NEXXT SPINE LLC	14-12-4530	00889929001189	Length 30 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-4535 NEXXT SPINE LLC	14-12-4535	00889929001202	Length 35 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-4543 NEXXT SPINE LLC	14-12-4543	00889929001226	Length 42.5 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-4548 NEXXT SPINE LLC	14-12-4548	00889929001240	Length 47.5 mm; Outer Diameter 4.5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5020 NEXXT SPINE LLC	14-12-5020	00889929001288	Length 20 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5033 NEXXT SPINE LLC	14-12-5033	00889929001325	Length 32.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5035 NEXXT SPINE LLC	14-12-5035	00889929001332	Length 35 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5040 NEXXT SPINE LLC	14-12-5040	00889929001349	Length 40 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5043 NEXXT SPINE LLC	14-12-5043	00889929001356	Length 42.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5045 NEXXT SPINE LLC	14-12-5045	00889929001363	Length 45 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5048 NEXXT SPINE LLC	14-12-5048	00889929001370	Length 47.5 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-5050 NEXXT SPINE LLC	14-12-5050	00889929001387	Length 50 mm; Outer Diameter 5 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System 14-12-6040 NEXXT SPINE LLC	14-12-6040	00889929024966	Length 40 mm; Outer Diameter 6.0 mm Prescription: no; Single use: yes	On the market
Facet Fixx™ Facet Screw System C14-01-04 NEXXT SPINE LLC	C14-01-04	00889929011584	Prescription: no; Single use: no	On the market
Facet Fixx™ Facet Screw System C14-01-05 NEXXT SPINE LLC	C14-01-05	00889929011591	Prescription: no; Single use: no	On the market
Facet Fixx™ Facet Screw System I14-01-01 NEXXT SPINE LLC	I14-01-01	00889929011461	Prescription: no; Single use: no	On the market
Facet Fixx™ Facet Screw System I14-02-01 NEXXT SPINE LLC	I14-02-01	00889929011478	Prescription: no; Single use: no	On the market

Similar devices

Other devices filed under FDA product code MRW (System, Facet Screw Spinal Device).

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Facet Fixx

Regulatory status

Coverage

Specification

Devices cleared under K131417

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Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K131417

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