Overwatch PCF · 33095-007
SPINAL ELEMENTS, INC. · Curved Rod, Ti, 4.0 mm X 60 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
- Curved Rod, Ti, 4.0 mm X 60 mm
- Public device record key
- e96a0e39-4624-4c7d-a9d6-65cf3f8f03ed
- 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
- 33095-007
- 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
- 00840606196536
- 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
- 65116
- Name
- Bone-screw internal spinal fixation system rod
- Implantable
- true
- Code status
- Active
- Definition
An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.