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SureMAX-X 1

by Additive Implants, Inc. 35 variants

SureMAX-X 1 (9101-07152005) is a Class I device made by Additive Implants, Inc., cleared under FDA 510(k) K193359 on 3 Jan 2020 and listed in FDA GUDID since 29 Apr 2020 (UDI-DI 00817662022437), 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

510(k) K193359

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817662022437 UDI-DI Date29 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK193359 Date3 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193359 decided 3 Jan 2020 Active
  • FDA GUDID UDI-DI 00817662022437 listed 29 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193359
  2. Listed FDA GUDID 00817662022437

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SureMAX-X
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
1, 9101-07152005
Primary DI / UDI-DI
00817662022437
510(k) Number
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 — 15 Millimeter
Width — 20 Millimeter
Height — 5 Millimeter

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K193359)

and 8 more cleared under K193359

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, reusable.

Other devices from Additive Implants, Inc.

  • SureMAX 1

    Class II

  • SureMAX-SA 1

    Class II

  • SureMAX-X 1

    Class I

  • SureMAX 1

    Class II

See all devices from Additive Implants, Inc. →

Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)