Modification To:Synthes (USA) Titanium Wire
FDA 510(k) K042606 · Synthes (Usa)
510(k) numberK042606
Submission
- Device name
- Modification To:Synthes (USA) Titanium Wire
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- September 24, 2004
- Decision date
- May 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4495
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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|---|---|---|---|
| K203855 | CoNextions TR Tendon Repair SystemGAQ · Traditional | Conextions Medical | 04/22/2022SE |
| K193209 | Wego-Stainless SteelGAQ · Traditional | Foosin Medical Supplies Inc., Ltd. | 02/19/2020SE |
| K172146 | MeristeelGAQ · Traditional | M/s. Meril Endo Surgery Private Limited. | 02/01/2018SE |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel SutureGAQ · Special | ETHICON, Inc. | 11/01/2017SE |
| K141007 | Demesteel (Stainless Steel) Non-Absorbable SutureGAQ · Traditional | Demetech Corp. | 09/25/2014SE |
| K140127 | Ferrofibre Stainless Steel Suture with CrimpGAQ · Special | Pontis Orthopaedics, LLC | 05/28/2014SE |
| K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5GAQ · Abbreviated | Core Essence Orthopaedics, LLC | 12/24/2008SE |
| K082828 | Suturtek 360 Degree Sternal Closure DeviceGAQ · Special | Suturtek Incorporated | 10/14/2008SE |
| K063603 | Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17GAQ · Abbreviated | Suturtek Incorporated | 02/07/2007SE |
| K041333 | Synthes (USA) Titanium WireGAQ · Traditional | Synthes (Usa) | 08/27/2004SE |
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| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateHRS · Traditional | 07/06/2012SE |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | 06/19/2012SE |
| K120854 | Synthes Va LCP Ankle Trauma SystemHRS · Traditional | 06/18/2012SE |
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Questions and answers
When was Modification To:Synthes (USA) Titanium Wire cleared by the FDA?
Modification To:Synthes (USA) Titanium Wire (K042606) received a 510(k) decision of Substantially Equivalent on May 27, 2005, 245 days after the submission was received.
What is the product code of K042606?
The FDA product code is GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, a Class II (moderate risk) device regulated under 21 CFR 878.4495.