Manufacturer
Globus Medical, Inc.VERZA™ High Speed Drills
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K233638
- Device name
- VERZA™ High Speed Drills
- Company
- Globus Medical, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2023-11-13
- Decision date
- 2024-02-09
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Spine SurgeryOther
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
VERZA™ High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures.
Intended Use
VERZA™ High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures.
Device Description
VERZA™ High Speed Drills are electrical drill handpieces/attachments powered by a motor with a control unit and foot pedal, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Burs are provided sterile and are single-use.
Summary parsed at:2026-06-19 05:29:38 UTC
Predicate devices
6Cited as predicate
1DuraPro™ Oscillating System
1 submission cite K233638 as a predicate