Alignment Instrument
FDA 510(k) K970345 · Richard Wolf Medical Instruments Corp.
510(k) numberK970345
Submission
- Device name
- Alignment Instrument
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- January 29, 1997
- Decision date
- April 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K942760 | Pneumatic Wire TensionerHSZ · Traditional | Smith & Nephew Richards, Inc. | 09/06/1994SE |
| K941681 | Arthrex Circular Harvesting SawHSZ · Traditional | Arthrex, Inc. | 08/25/1994SE |
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Questions and answers
When was Alignment Instrument cleared by the FDA?
Alignment Instrument (K970345) received a 510(k) decision of Substantially Equivalent on April 29, 1997, 90 days after the submission was received.
What is the product code of K970345?
The FDA product code is HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.