Skip to content

Curiteva Navigation System C595-305-55

by Curiteva, LLC

Curiteva Navigation System C595-305-55 is a Class II device made by Curiteva, LLC, cleared under FDA 510(k) K223200 on 6 Jan 2023 and listed in FDA GUDID since 2 Jul 2026 (UDI-DI B648C595305550), 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) K223200

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 NumberB648C595305550 UDI-DI Date2 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223200 Date6 Jan 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223200 decided 6 Jan 2023 Active
  • FDA GUDID UDI-DI B648C595305550 listed 2 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223200
  2. Listed FDA GUDID B648C595305550

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Curiteva Navigation System
Generic name
Bone tap, reusable
Model / reference
C595-305-55
Primary DI / UDI-DI
B648C595305550
510(k) Number
FDA product code
OLO
GMDN term
Bone tap, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5.5 Millimeter

Related devices

Cleared under the same submission (K223200)

and 8 more cleared under K223200

Similar devices

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

Other devices from Curiteva, LLC

See all devices from Curiteva, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)