Acapella Cervical Spacer System

by Choicespine, LP

510(k) K171489

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) K171489↗

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	NumberK171489	Date23 Oct 2017Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K171489

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K171489
FDA product code: OVE

Device class: Class II
Regulation: 21 CFR Part 888.3080
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Acapella Cervical Spacer System is an interbody fusion device designed for anterior cervical procedures. It is classified as an orthopedic implant intended to restore spinal stability and facilitate bone fusion in the cervical spine, addressing degenerative disc disease at a single level from C2 to T1.

This system is supplied sterile and intended for single-use in surgical settings. It is regulated under FDA 510(k) clearance (K171489) and manufactured by Choicespine, LP. The device is available in specific sizes tailored for cervical interbody fusion, with no noted MRI compatibility restrictions. Storage and handling must comply with sterile surgical protocols.

Devices cleared under K171489

129 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 K171489
		UDI-DI	Size and differences
BLACKHAWK Cervical Spacer System 05-090-21-1605 Choicespine, LP	05-090-21-1605	00840996164474	Width 16 mm; Depth 14 mm; Height 5 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-21-1606 Choicespine, LP	05-090-21-1606	00840996164481	Height 6 mm; Width 16 mm; Depth 14 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-21-1607 Choicespine, LP	05-090-21-1607	00840996164498	Depth 14 mm; Width 16 mm; Height 7 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-21-1608 Choicespine, LP	05-090-21-1608	00840996164504	Depth 14 mm; Height 8 mm; Width 16 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-21-1610 Choicespine, LP	05-090-21-1610	00840996164528	Width 16 mm; Depth 14 mm; Height 10 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-22-1407 Choicespine, LP	05-090-22-1407	00840996164559	Height 7 mm; Depth 12 mm; Width 14 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-22-1410 Choicespine, LP	05-090-22-1410	00840996164580	Height 10 mm; Width 14 mm; Depth 12 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-22-1606 Choicespine, LP	05-090-22-1606	00840996164603	Height 6 mm; Depth 14 mm; Width 16 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-22-1607 Choicespine, LP	05-090-22-1607	00840996164610	Width 16 mm; Depth 14 mm; Height 7 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-22-1609 Choicespine, LP	05-090-22-1609	00840996164634	Width 16 mm; Height 9 mm; Depth 14 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-22-1610 Choicespine, LP	05-090-22-1610	00840996164641	Width 16 mm; Height 10 mm; Depth 14 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-23-1406 Choicespine, LP	05-090-23-1406	00840996164665	Height 6 mm; Width 14 mm; Depth 12 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-23-1407 Choicespine, LP	05-090-23-1407	00840996164672	Width 14 mm; Depth 12 mm; Height 7 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-23-1408 Choicespine, LP	05-090-23-1408	00840996164689	Width 14 mm; Depth 12 mm; Height 8 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-23-1410 Choicespine, LP	05-090-23-1410	00840996164702	Width 14 mm; Depth 12 mm; Height 10 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-23-1609 Choicespine, LP	05-090-23-1609	00840996164757	Depth 14 mm; Height 9 mm; Width 16 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-090-23-1610 Choicespine, LP	05-090-23-1610	00840996164764	Depth 14 mm; Width 16 mm; Height 10 mm Single use: yes	On the market
BLACKHAWK Cervical Spacer System 05-099-01-3200 Choicespine, LP	05-099-01-3200	00840996164900	Single use: no	On the market
BLACKHAWK Cervical Spacer System 05-099-02-4200 Choicespine, LP	05-099-02-4200	00840996164887	Single use: no	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412007 Choicespine, LP	S-TT10-1412007	00840996182485	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412008 Choicespine, LP	S-TT10-1412008	00840996182492	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412010 Choicespine, LP	S-TT10-1412010	00840996182515	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412605 Choicespine, LP	S-TT10-1412605	00840996182126	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412607 Choicespine, LP	S-TT10-1412607	00840996182140	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412608 Choicespine, LP	S-TT10-1412608	00840996182157	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412609 Choicespine, LP	S-TT10-1412609	00840996182164	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412610 Choicespine, LP	S-TT10-1412610	00840996182171	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1412C06 Choicespine, LP	S-TT10-1412C06	00840996182195	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1614607 Choicespine, LP	S-TT10-1614607	00840996182263	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1614C08 Choicespine, LP	S-TT10-1614C08	00840996182331	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1614C09 Choicespine, LP	S-TT10-1614C09	00840996182348	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT10-1614C10 Choicespine, LP	S-TT10-1614C10	00840996182355	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412005 Choicespine, LP	S-TT20-1412005	00840996186506	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412007 Choicespine, LP	S-TT20-1412007	00840996186520	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412010 Choicespine, LP	S-TT20-1412010	00840996186551	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412605 Choicespine, LP	S-TT20-1412605	00840996186445	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412606 Choicespine, LP	S-TT20-1412606	00840996186452	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412609 Choicespine, LP	S-TT20-1412609	00840996186483	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412610 Choicespine, LP	S-TT20-1412610	00840996186490	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412C07 Choicespine, LP	S-TT20-1412C07	00840996186582	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1412C08 Choicespine, LP	S-TT20-1412C08	00840996186599	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1614005 Choicespine, LP	S-TT20-1614005	00840996186681	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1614006 Choicespine, LP	S-TT20-1614006	00840996186698	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1614008 Choicespine, LP	S-TT20-1614008	00840996186711	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1614605 Choicespine, LP	S-TT20-1614605	00840996186629	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1614606 Choicespine, LP	S-TT20-1614606	00840996186636	Single use: yes	On the market
BLACKHAWK Cervical Spacer System S-TT20-1614C10 Choicespine, LP	S-TT20-1614C10	00840996186797	Single use: yes	On the market
BLACKHAWK Cervical Spacer System T070-0004 Choicespine, LP	T070-0004	00840996182386	Single use: no	On the market
BLACKHAWK Cervical Spacer System T070-0009B Choicespine, LP	T070-0009B	00840996188081	Single use: no	On the market
Blackhawk T070-0004B Choicespine, LP	T070-0004B	00840996184731	Single use: no	On the market

Other devices from Choicespine, LP

See all devices from Choicespine, LP →

Acapella Cervical Spacer System

Regulatory status

Coverage

Specification

Overview

Devices cleared under K171489

Other devices from Choicespine, LP

Boomerang BT20-D4513

Boomerang BT20-D4515

Boomerang BT20-D4517

Boomerang B070-0000

Regulatory status

Coverage

Specification

Related clearances

Cites

Cited by

Overview

Devices cleared under K171489

Other devices from Choicespine, LP

Boomerang BT20-D4513

Boomerang BT20-D4515

Boomerang BT20-D4517

Boomerang B070-0000