Overwatch PCF · 33093-013
SPINAL ELEMENTS, INC. · Translation Screw, Cervical, 4.2 mm X 32 mm
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Device description
- Translation Screw, Cervical, 4.2 mm X 32 mm
- Public device record key
- ac8e92ed-144c-41ef-af8a-12d2677da21c
- Has serial number
- false
- Public version date
- 2026-08-03
- Is direct marking exempt
- false
- Public version number
- 1
- Labeler duns number
- 610712213
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- 33093-013
- Has manufacturing date
- false
- Brand name
- Overwatch PCF
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Company name
- SPINAL ELEMENTS, INC.
- Public version status
- New
- Has expiration date
- false
- Is hct p
- false
- Publish date
- 2026-07-24
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- true
- Sterilization methods
- Moist Heat or Steam Sterilization
- Identifiers
- ID
- 00840606195423
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- NKG
- Name
- Posterior Cervical Screw System
- Harmonized identifiers (openFDA)
- Device name
- Posterior Cervical Screw System
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3075
- Device class
- 2
- Customer contacts
- Phone
- 7606070121
- customerservice@spinalelements.com
- Gmdn terms
- Code
- 46651
- Name
- Spinal bone screw, non-bioabsorbable
- Implantable
- true
- Code status
- Active
- Definition
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.