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Surfix 285120SND

by Newdeal Sas

Surfix 285120SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K083154 on 10 Jul 2009 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780048756), 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 ongoing

1 closed

Documents

510(k) K083154

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 Number10381780048756 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083154 Date10 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083154 decided 10 Jul 2009 Active
  • FDA GUDID UDI-DI 10381780048756 listed 9 Oct 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-1147-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011 on shared 510(k) K083154

    Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K083154
  2. Recall initiated FDA recalls Z-1147-2012
  3. Listed FDA GUDID 10381780048756

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  • Withdrawn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
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Ref / Catalog
285120SND
Primary DI / UDI-DI
10381780048756
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K083154)

and 8 more cleared under K083154

Similar devices in this category

Other devices filed under Orthopaedic bone screw, non-bioabsorbable, sterile.

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)