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SkyWalker NB-10199

by Microport Navibot International LLC

SkyWalker NB-10199 is a Class II device made by Microport Navibot International LLC, cleared under FDA 510(k) K213873 on 7 Jul 2022 and listed in FDA GUDID since 24 Apr 2025 (UDI-DI 00850030914347), 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) K213873

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 Number00850030914347 UDI-DI Date24 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213873 Date7 Jul 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213873 decided 7 Jul 2022 Active
  • FDA GUDID UDI-DI 00850030914347 listed 24 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213873
  2. Listed FDA GUDID 00850030914347

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SkyWalker
Generic name
Optical surgical tracking system spatial marker, single-use
Model / Ref / Catalog
NB-10199
Primary DI / UDI-DI
00850030914347
510(k) Number
FDA product code
OLO
GMDN term
Optical surgical tracking system spatial marker, single-use
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical optical-tracking spatial marker, single-use

Cleared under the same submission (K213873)

and 8 more cleared under K213873

Similar devices

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

Other devices from Microport Navibot International LLC

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    Class II

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    Class II

  • 10038-Nb

    Class II

See all devices from Microport Navibot International LLC →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)