AxTiHA® Stand-Alone ALIF System
Innovasis · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Salt Lake City
- Advisory committee description
- Orthopedic
- Address 1
- 614 E 3900 S
- Statement or summary
- Summary
- Product code
- OVD
- Zip code
- 84107
- Applicant
- Innovasis
- Decision date
- 2025-03-24
- Decision code
- SESE
- Country code
- US
- Device name
- AxTiHA® Stand-Alone ALIF System
- Advisory committee
- OR
- Contact
- Mr. Mike Thomas
- K number
- K250603
- State
- UT
- Date received
- 2025-02-28
- Review advisory committee
- OR
- Postal code
- 84107
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- 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
- 3007766698, 9610612, 3018094310, 1000432246, 3005739886, 3008868758, 3007303113, 8020776, 1057425, 8043792, 3015876273, 1226544, 2532027, 1724955, 3008262872, 3013194153, 3010047402, 3005180920, 3005706667, 3015212339, 3007993775, 3012491394, 2134285, 3009051471, 3008864603, 3009887475, 3019837678, 3006846753, 3030412764, 3010370554, 3008114965, 3015216945, 3015151147, 3003477135, 3010866843, 3005641619, 3013820501, 3033509898, 2134470, 3008812560 +224 more
- FEI number
- 3007766698, 1000477302, 3018094310, 1000432246, 3000718490, 3008868758, 3005739886, 3007303113, 3015876273, 4224, 3001237338, 3008262872, 3013194153, 3010047402, 3005180920, 3003058119, 3005706667, 3015212339, 3007993775, 1000139987, 3002808269, 1000069183, 3012491394, 1000306303, 3009051471, 3008864603, 3009887475, 3019837678, 3011764740, 3006846753, 3003015552, 3030412764, 3010370554, 3008114965, 3015216945, 3015151147, 3003477135, 3010866843, 3003690049, 3013820501 +224 more