Distractor 86601

by Premia Spine Ltd

Distractor 86601 is a Class II device made by Premia Spine Ltd, cleared under FDA 510(k) K232719 on 21 Nov 2023 (4 earlier submissions) and listed in FDA GUDID since 10 Oct 2024 (UDI-DI 07290115935561), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

+4 more

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290115935561 UDI-DI	Date10 Oct 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK232719	Date21 Nov 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK231844	Date7 Jul 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK182598	Date13 Nov 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK170061	Date2 Feb 2017Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK150380	Date17 Jul 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290115935561
FDA 510(k) database 510(k) number K232719
FDA 510(k) database 510(k) number K231844
FDA 510(k) database 510(k) number K182598
FDA 510(k) database 510(k) number K170061
FDA 510(k) database 510(k) number K150380

Across registries

2 registries list this device

FDA 510(k) K232719 decided 21 Nov 2023 Active· +4 more in the status table
FDA GUDID UDI-DI 07290115935561 listed 10 Oct 2024 Listed

Timeline

6 dated events

17 Jul 2015 Cleared FDA 510(k) K150380
2 Feb 2017 Cleared FDA 510(k) K170061
13 Nov 2018 Cleared FDA 510(k) K182598
7 Jul 2023 Cleared FDA 510(k) K231844
21 Nov 2023 Cleared FDA 510(k) K232719
10 Oct 2024 Listed FDA GUDID 07290115935561

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Distractor
Generic name: Orthopaedic surgical distractor, internal
Model / reference: 86601

Primary DI / UDI-DI: 07290115935561
510(k) Number: K150380
K170061
K182598
K231844
K232719
FDA product code: NKB, MNH, MNI
GMDN term: Orthopaedic surgical distractor, internal

Device class: Class II
Regulation number: 888.3070
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Premia Spine Ltd

XL Adaptor 87146 Open recall

Class II
XL Screwdriver CM 89197 Open recall

Class II
Screwdriver CM 89173 Open recall

Class II
Tube for K-wire over a k-wire technique 470mm (Nitinol) 89289 Open recall

Class II

See all devices from Premia Spine Ltd →

Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)