311.068.01S

311.068.01S (31106801S) is a Class II device made by Synthes, cleared under FDA 510(k) K153587 on 18 Jan 2017 and listed in FDA GUDID since 20 Apr 2017 (UDI-DI 10887587035918), active as of 23 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10887587035918 UDI-DI	Date20 Apr 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153587	Date18 Jan 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10887587035918
FDA 510(k) database 510(k) number K153587

Across registries

2 registries list this device

FDA 510(k) K153587 decided 18 Jan 2017 Active
FDA GUDID UDI-DI 10887587035918 listed 20 Apr 2017 Listed

Timeline

2 dated events

18 Jan 2017 Cleared FDA 510(k) K153587
20 Apr 2017 Listed FDA GUDID 10887587035918

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Bone tap, single-use
Model / Ref / Catalog: 311.068.01S, 31106801S

Primary DI / UDI-DI: 10887587035918
510(k) Number: K153587
FDA product code: HBG
GMDN term: Bone tap, single-use

Device class: Class II
Regulation number: 882.4300
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)