Astura Medical
FDA registration: United States Last updated 25 Oct 2026
- Devices
- 14,707
- Registries
- GUDIDFDA
- FDA recalls
- 0
Catalogue
Olympic AZC010030 Ref AZC010030
Olympic AZC170000 Ref AZC170000
Na MZA010000 Ref MZA010000
Na MZA030050 Ref MZA030050
Na MZA03A060 Ref MZA03A060
Na MZA03A090 Ref MZA03A090
Na MZA03A070 Ref MZA03A070
Na MZA03A080 Ref MZA03A080
Na MZA03A100 Ref MZA03A100
Na MZA03A110 Ref MZA03A110
Na MZA03A120 Ref MZA03A120
Na MZA040000 Ref MZA040000
Na MZA050000 Ref MZA050000
Na MZA07AA02 Ref MZA07AA02
Na MZA07AA03 Ref MZA07AA03
Na MZA060000 Ref MZA060000
Na MZA051000 Ref MZA051000
Na MZA07AA01 Ref MZA07AA01
Na MZA07AA04 Ref MZA07AA04
Na MZA07AA05 Ref MZA07AA05
Na MZA080000 Ref MZA080000
Na MZA090000 Ref MZA090000
Na MZA110000 Ref MZA110000
Na MZA100000 Ref MZA100000
Na NZA035065 Ref NZA035065
Na NZA035075 Ref NZA035075
Na NZA035085 Ref NZA035085
Na NZA035095 Ref NZA035095
Na NZA035105 Ref NZA035105
Na NZA034065 Ref NZA034065
Na NZA034075 Ref NZA034075
Na NZA034085 Ref NZA034085
Na NZA034095 Ref NZA034095
Na NZA034105 Ref NZA034105
Na MZA120000 Ref MZA120000
Alta NBF045025 Ref NBF045025
Alta NBT045025 Ref NBT045025
Alta NBF095060 Ref NBF095060
Alta NBT095060 Ref NBT095060
Na NBV075050 Ref NBV075050
Na NBV075060 Ref NBV075060
Na NBV075100 Ref NBV075100
Na NBV075130 Ref NBV075130
Na NBV075110 Ref NBV075110
Na NBV085050 Ref NBV085050
Na NBV075140 Ref NBV075140
Na NBV075120 Ref NBV075120
Na NBV075090 Ref NBV075090
Na NBV075080 Ref NBV075080
Na NBV085060 Ref NBV085060
Showing 1-50 of 14,707
What Astura Medical makes
Astura Medical designs and manufactures spinal fixation and fusion systems, including modular posterior fixation devices, anterior lumbar and cervical interbody fusion implants, deformity correction bands, and navigated surgical instruments for spinal procedures.
The company’s products are classified as Class II medical devices under FDA regulations, with all listed via the 510(k) pathway. These devices are intended for spinal stabilization and correction in surgical settings and are based in the United States.
Frequently asked questions
What types of medical devices does Astura Medical manufacture?
Astura Medical specializes in spinal fixation and fusion systems. Their portfolio includes modular posterior spinal fixation devices like the MASADA and OLYMPIC systems, anterior lumbar and cervical interbody fusion implants such as EL CAPITAN and ALTA, deformity correction tools like the OLYMPIC Deformity Band System, and navigated surgical instruments like BridalVeil. These devices are designed to stabilize and correct spinal alignment in surgical procedures.
Where is Astura Medical based?
Astura Medical is headquartered in the United States. The company’s focus on spinal fixation and fusion systems aligns with the regulatory framework of the FDA, which governs medical device authorization in the country.
Which regulatory registries or databases list Astura Medical’s devices?
Astura Medical’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II medical devices, which require a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device before commercialization.
How are Astura Medical’s devices classified under FDA regulations?
Astura Medical’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. The 510(k) pathway is used to demonstrate compliance with these controls.
Information
- FDA registration
- United States
- Address
- 4949 W Royal Ln, Irving, TX, 75063
- Website
- asturamedical.com
- [email protected]
- Phone
- 7608148047
- FDA FEI number
- 3011764740
- DUNS number
- 073029645