Wright Medical Technology Sawblades
FDA 510(k) K955229 · Wrightmedicaltechnologyinc
510(k) numberK955229
Submission
- Device name
- Wright Medical Technology Sawblades
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- November 14, 1995
- Decision date
- January 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GFA – Blade, Saw, General & Plastic Surgery, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GFA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971978 | Graft Harvesting SawbladesGFA · Traditional | Wrightmedicaltechnologyinc | 06/18/1997SE |
| K954483 | Stryker Sagittal Saw AttachmentGFA · Traditional | Stryker Instruments | 01/30/1996SE |
| K953012 | Disposable & Reusable Surgical Cutting ToolsGFA · Traditional | Boston Surgical Products, Inc. | 07/12/1995SE |
| K950403 | Surgical Saw BladesGFA · Traditional | Transidyne General Corp. | 02/21/1995SE |
| K940501 | Re-Sharpenable Saw BladesGFA · Traditional | Adven Medical | 06/28/1994SE |
| K933595 | Bur, Surgical, General & Plastic SurgeryGFA · Traditional | Omega Surgical Instruments, Inc. | 03/16/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 3M Health Care, Sarns | 02/24/1994SE |
| K934603 | Surgical Saw BladesGFA · Traditional | American Medical Specialties, Inc. | 02/22/1994SE |
| K931769 | Snap Oscillating SawGFA · Traditional | Surgiquip, Inc. | 01/27/1994SE |
| K934390 | Oscillating Bone Saw Blade, 6200 SeriesGFA · Traditional | Boehringer Laboratories | 01/26/1994SE |
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Questions and answers
When was Wright Medical Technology Sawblades cleared by the FDA?
Wright Medical Technology Sawblades (K955229) received a 510(k) decision of Substantially Equivalent on January 18, 1996, 65 days after the submission was received.
What is the product code of K955229?
The FDA product code is GFA – Blade, Saw, General & Plastic Surgery, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4820.