Itm Sonic Surgery System
FDA 510(k) K912931 · Buckman Co., Inc.
510(k) numberK912931
Submission
- Device name
- Itm Sonic Surgery System
- Applicant
- Buckman Co., Inc.
Concord, CA, US - Received
- July 5, 1991
- Decision date
- October 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
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Questions and answers
When was Itm Sonic Surgery System cleared by the FDA?
Itm Sonic Surgery System (K912931) received a 510(k) decision of Substantially Equivalent on October 3, 1991, 90 days after the submission was received.
What is the product code of K912931?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.