Skip to content

Neonail 932.201

by Neoortho Produtos Ortopédicos S/A.

Neonail 932.201 is a Class II device made by Neoortho Produtos Ortopédicos S/A., cleared under FDA 510(k) K141103 on 23 Sep 2014 and listed in FDA GUDID since 7 Oct 2015 (UDI-DI 07899893203260), 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) K141103

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 Number07899893203260 UDI-DI Date7 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141103 Date23 Sep 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141103 decided 23 Sep 2014 Active
  • FDA GUDID UDI-DI 07899893203260 listed 7 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141103
  2. Listed FDA GUDID 07899893203260

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neonail
Generic name
Bone nail implantable cap
Model / reference
932.201
Primary DI / UDI-DI
07899893203260
510(k) Number
FDA product code
HSB
GMDN term
Bone nail implantable cap
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone nail end-cap

Cleared under the same submission (K141103)

and 8 more cleared under K141103

Other devices from Neoortho Produtos Ortopédicos S/A.

See all devices from Neoortho Produtos Ortopédicos S/A. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)