K902959Substantially Equivalent
Norland Xr26 Lateral Spine Option
Norland Corp., Fort Atkinson WI / Traditional, Substantially Equivalent
K902959 is the FDA 510(k) clearance record for NORLAND XR26 LATERAL SPINE OPTION, a class II device, cleared for Norland Corp. on under FDA product code KGI (Densitometer, Bone). FDA records list 15 510(k) clearances for Norland Corp., from to . As of , FDA records show no recalls naming K902959.
Clearance record
- Decision date
- Received
- (141 days to decision)
- Product code
- KGI Densitometer, Bone
- Regulation
- 21 CFR 892.1170
- Device class
- Class II
- Review panel
- Radiology
- Applicant
- Norland Corp. W6340 Hackbarth Rd., Fort Atkinson WI
- Third party review
- No
Clearances, product code KGI
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 1 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
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