510(k) Report

FDA applicant

Newdeal Sas

Planisboro, NJ10 decisions2007–201213 recalls

FDA records 10 decisions for Newdeal Sas (Planisboro, NJ) from 2007 to 2012: 10 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 19 predicates, 3 of them its own earlier devices. 13 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Newdeal Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 32008: 12009: 32010: 12011: 12012: 1
2007high 3 (2007) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2022

2008: 12010: 12011: 12013: 12014: 12016: 12017: 12018: 52022: 1
2007high 5 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Newdeal Sas by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone7decisions
  • HWCScrew, Fixation, Bone1decision
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • HTYPin, Fixation, Smooth1decision

Whose devices does it build on?

Its devices cite 19 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 20096cite it
  • K073375Newdeal Tibiaxys SystemNewdeal Sas · 20086cite it
  • K071639Qwix Positioning ScrewNewdeal Sas · 20075cite it
  • K070447Newdeal Compression PlateNewdeal Sas · 20073cite it
  • K083154Newdeal Hallu Lock Plate SystemNewdeal Sas · 20092cite it
  • K093914Newdeal Compression PlatesNewdeal Sas · 20111cites it

What has FDA decided for it lately?

  • K103623Newdeal Interphalangeal ImplantNewdeal Sas · 2012
  • K093914Newdeal Compression PlatesNewdeal Sas · 20115 recalls
  • K093781Modified: Newdeal Hallu PlatesNewdeal Sas · 2010
  • K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 20092 recalls
  • K083154Newdeal Hallu Lock Plate SystemNewdeal Sas · 20091 recall
  • K091609Newdeal Compression PlateNewdeal Sas · 20091 recall
  • K073375Newdeal Tibiaxys SystemNewdeal Sas · 20082 recalls
  • K071639Qwix Positioning ScrewNewdeal Sas · 20071 recall

All 10 as Newdeal Sas →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K073375INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 NDJan 4, 2022Class II
  • K093914Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S…May 22, 2018Class II
  • K093914UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S…May 22, 2018Class II
  • K093914TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S…May 22, 2018Class II
  • K093914ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S…May 22, 2018Class II
  • K093914ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S…May 22, 2018Class II