SureMAX 1

by Additive Implants, Inc. 146 variants

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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817662024240 UDI-DI	Date21 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK182477	Date28 Jan 2019Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: SureMAX
Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference: 1

Primary DI / UDI-DI: 00817662024240
510(k) Number: K182477
FDA product code: LXH
GMDN term: Orthopaedic prosthesis implantation positioning instrument, reusable

Device class: Class I
Regulation number: 888.4540
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Angle — 7 degree
Depth — 12 Millimeter
Width — 14 Millimeter
Height — 3.5 Millimeter

Other devices from Additive Implants, Inc.

SureMAX 1

Class II
SureMAX-X 1

Class I
SureMAX-SA 1

Class II
SureMAX 1

Class II
SureMAX 1

Class I
SureMAX 1

Class I

See all devices from Additive Implants, Inc. →

Properties

Sterilise before use
Lot / batch number

Other properties (13)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Prescription use: 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