Manufacturer
Alphatec Spine, Inc.ATEC Posterior Navigated Disc Prep Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K232345
- Device name
- ATEC Posterior Navigated Disc Prep Instruments
- Company
- Alphatec Spine, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2023-08-04
- Decision date
- 2023-11-02
- Submission type
- Traditional
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
1Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
1 submission cite K232345 as a predicate