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EXPert Nail 04.013.000S

by Synthes GmbH

EXPert Nail 04.013.000S (04013000S) is a Class II device made by Synthes GmbH, cleared under FDA 510(k) K033618 on 5 Feb 2004 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982087355), active as of 12 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K033618

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982087355 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033618 Date5 Feb 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033618 decided 5 Feb 2004 Active
  • FDA GUDID UDI-DI 10886982087355 listed 14 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-2058-2013 FDA Class II initiated 2 Nov 2012

    Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

Timeline

3 dated events

  1. Cleared FDA 510(k) K033618
  2. Recall initiated FDA recalls Z-2058-2013
  3. Listed FDA GUDID 10886982087355

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EXPert Nail
Generic name
Bone nail implantable cap
Model / Ref / Catalog
04.013.000S, 04013000S
Primary DI / UDI-DI
10886982087355
510(k) Number
FDA product code
HWC, HSB
GMDN term
Bone nail implantable cap
Device class
Class II
Regulation number
888.3040, 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 (K033618)

and 8 more cleared under K033618

Similar devices in this category

Other devices filed under Bone nail end-cap.

Other devices from Synthes GmbH

  • Tomofix

    Class IIb

  • 03.111.100S

    Class IIb

  • 68.134.011

    Class II

  • Volt 68.134.111

    Class II

See all devices from Synthes GmbH →

Properties

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