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Surfix 185300ND

by Newdeal Sas

Surfix 185300ND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K091609 on 30 Jun 2009 (3 earlier submissions) and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780048480), active as of 23 Oct 2026. 3 FDA recalls are 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

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780048480 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK091609 Date30 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091609 decided 30 Jun 2009 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10381780048480 listed 9 Oct 2017 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2123-2012 FDA Class II initiated 9 Feb 2012

    Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.

    • Terminated Z-0955-2011 FDA Unclassified (pre-2012) initiated 18 Nov 2010

    Integra LifeSciences Corporation has decided to initiate a voluntary recall of the Uni-Comp Kits due to inaccurate information relative to the recommended sterilization parameters described in the products Instructions for Use (IFU). The sterilization parameters noted in the Uni-Comp IFU were incorrect. It is noted that the sterilization recommendations in the UNI-Comp IFU in which the Exposure

    • Terminated Z-0307-2009 FDA Unclassified (pre-2012) initiated 30 Sep 2008

    Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate

Timeline

8 dated events

  1. Cleared FDA 510(k) K063820
  2. Cleared FDA 510(k) K070241
  3. Cleared FDA 510(k) K070447
  4. Recall initiated FDA recalls Z-0307-2009
  5. Cleared FDA 510(k) K091609
  6. Recall initiated FDA recalls Z-0955-2011
  7. Recall initiated FDA recalls Z-2123-2012
  8. Listed FDA GUDID 10381780048480

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surfix
Generic name
Implantable bone washer
Model / Ref / Catalog
185300ND
Primary DI / UDI-DI
10381780048480
510(k) Number
FDA product code
HRS
GMDN term
Implantable bone washer
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Implantable bone washer

Cleared under the same submission (K063820)

and 8 more cleared under K063820

Cleared under the same submission (K070241)

and 8 more cleared under K070241

Similar devices in this category

Other devices filed under Implantable bone washer.

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)