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Mako TKA 1.0.3+ THA 4.1.1 + PKA 3.0.4

by MAKO Surgical Corp.

Mako TKA 1.0.3+ THA 4.1.1 + PKA 3.0.4 (700002145692) is a Class II device made by MAKO Surgical Corp., cleared under FDA 510(k) K193128 on 2 Feb 2020 and listed in FDA GUDID since 21 Jul 2023 (UDI-DI 07613327600001), 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

510(k) K193128

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327600001 UDI-DI Date21 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193128 Date2 Feb 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193128 decided 2 Feb 2020 Active
  • FDA GUDID UDI-DI 07613327600001 listed 21 Jul 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193128
  2. Listed FDA GUDID 07613327600001

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mako
Generic name
Robotic surgical navigation system application software
Model / Ref / Catalog
TKA 1.0.3+ THA 4.1.1 + PKA 3.0.4, 700002145692
Primary DI / UDI-DI
07613327600001
510(k) Number
FDA product code
OLO
GMDN term
Robotic surgical navigation system application software
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Robotic surgical navigation system application software

Cleared under the same submission (K193128)

and 1 more cleared under K193128

Similar devices

Other devices filed under FDA product code OLO (Orthopedic stereotaxic instrument).

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

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