03.168.009

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10886982274434 UDI-DI	Date25 Apr 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK172872	Date5 Mar 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10886982274434
FDA 510(k) database 510(k) number K172872

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthopaedic implantation sleeve, reusable
Model / Ref / Catalog: 03.168.009, 03168009

Primary DI / UDI-DI: 10886982274434
510(k) Number: K172872
FDA product code: KTT
GMDN term: Orthopaedic implantation sleeve, reusable

Device class: Class II
Regulation number: 888.3030
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No