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SkyWalker NB-10148

by Microport Navibot International LLC

SkyWalker NB-10148 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 29 Jun 2023 (UDI-DI 20850030914266), 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) K213873

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 Number20850030914266 UDI-DI Date29 Jun 2023ListedStatusListed 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 20850030914266 listed 29 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213873
  2. Listed FDA GUDID 20850030914266

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  • Withdrawn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
Orthopaedic bone pin, non-bioabsorbable
Model / Ref / Catalog
NB-10148
Primary DI / UDI-DI
20850030914266
510(k) Number
FDA product code
OLO
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (K213873)

and 8 more cleared under K213873

Similar devices in this category

Other devices filed under Orthopaedic bone pin, non-bioabsorbable.

Other devices from Microport Navibot International LLC

  • 10034-Nb

    Class II

  • B.B6.050-Nb

    Class II

  • 10031-Nb

    Class II

  • 10038-Nb

    Class II

See all devices from Microport Navibot International LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
Other properties (11, all answered No)