FDA.reportPublic FDA data

OVERWATCH

Primary DI
00840916132002
Brand
OVERWATCH
Company
SPINAL ELEMENTS
Model
108-ET-6550DC
Device description
OVERWATCH® 6.5MM x 50MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
Published
2017-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916132002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916132002008409161320028409161320020840916132002

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916143084PIRANHACSVS-425-162021-01-09
00840916143091PIRANHACSVS-425-182021-01-09
00840916135119BLACK WIDOWTBS0452021-01-07
00840916135126BLACK WIDOWTBS0502021-01-07
00840916135133BLACK WIDOWTBS0552021-01-07
00840916103941DIAMOND6-1-302017-05-23
00840916103958DIAMOND6-1-322017-05-23
00840916103965DIAMOND6-1-342017-05-23
00840916103972DIAMOND6-2-362017-05-23
00840916103989DIAMOND6-2-392017-05-23
00840916103996DIAMOND6-2-422017-05-23
00840916104009DIAMOND6-2-452017-05-23
00840916104016DIAMOND6-2-482017-05-23
00840916104023DIAMOND6-2-512017-05-23
00840916104030DIAMOND6-3-532017-05-23
00840916104047DIAMOND6-2-542017-05-23
00840916104054DIAMOND6-3-562017-05-23
00840916104061DIAMOND6-3-592017-05-23
00840916104078DIAMOND6-3-622017-05-23
00840916104085DIAMOND6-3-652017-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13