ATEC IOM Accessory Instruments— 510(k) K221821
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K221821 for ATEC IOM Accessory Instruments, Substantially Equivalent on 2022-09-23. Applicant: Alphatec Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.