SABER-XA System
Elevation Spine · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Monteray
- Advisory committee description
- Orthopedic
- Address 1
- 2511 Garden Rd.
- Address 2
- Suite B125
- Statement or summary
- Summary
- Product code
- OVD
- Zip code
- 93940
- Applicant
- Elevation Spine
- Decision date
- 2026-08-03
- Decision code
- SESE
- Country code
- US
- Device name
- SABER-XA System
- Advisory committee
- OR
- Contact
- John Kirwan
- K number
- K261408
- State
- CA
- Date received
- 2026-04-30
- Review advisory committee
- OR
- Postal code
- 93940
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3080
- Device class
- 2
- Registration number
- 1835251, 3009380063, 3011127597, 1526711, 3007922509, 3010097171, 1834331, 3012120772, 3010047454, 3010326971, 3014252644, 9617544, 2029275, 1000432246, 3010462278, 1225492, 3006982954, 3010057495, 3012447612, 2648623, 3005061536, 3010386387, 3012428435, 3004635447, 3009149199, 3004774118, 1030489, 3009241418, 3004638600, 3037407500, 9616680, 3010120326, 1833920, 3017048829, 3007344102, 3008110533, 3010705004, 3003639920, 3009144915, 3010663372 +222 more
- FEI number
- 3002980729, 3002806315, 1000514086, 3009380063, 3011127597, 1526711, 3007922509, 3010097171, 3012120772, 3010047454, 3010326971, 3014252644, 1000116116, 1000432246, 3010462278, 3008647423, 3010057495, 3012447612, 2648623, 3005061536, 3010386387, 3012428435, 3004635447, 3009149199, 3003292403, 3009241418, 3004638600, 3037407500, 3002459190, 3010120326, 3017048829, 3002807113, 3007344102, 3008110533, 3010705004, 3003639920, 3009144915, 3010663372, 1450662, 3008773560 +222 more