510(k) K837776
K837776 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "AOR X-RAY ALIGMENT PAD". The FDA issued a decision of Substantially Equivalent on August 18, 1983. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1983
- Date Received
- January 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Grid, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1910
- Review Panel
- RA
- Submission Type