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SureMAX 1

by Additive Implants, Inc. 146 variants

SureMAX 1 is a medical device (FDA Class I; FDA product code LXH, Orthopedic Manual Surgical Instrument) made by Additive Implants, Inc., cleared under FDA 510(k) K182477 on 28 Jan 2019 and listed in FDA GUDID since 21 Feb 2019 (UDI-DI 00817662024028), 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) K182477

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 Number00817662024028 UDI-DI Date21 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182477 Date28 Jan 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182477 decided 28 Jan 2019 Active
  • FDA GUDID UDI-DI 00817662024028 listed 21 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182477
  2. Listed FDA GUDID 00817662024028

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
00817662024028
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 — 0 degree
Depth — 12 Millimeter
Width — 14 Millimeter
Height — 8 Millimeter

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K182477)

and 8 more cleared under K182477

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-X 1

    Class I

  • SureMAX-SA 1

    Class II

  • SureMAX 1

    Class II

See all devices from Additive Implants, Inc. →

Properties

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