FDA.reportPublic FDA data

OVERWATCH

Primary DI
00840916130602
Brand
OVERWATCH
Company
SPINAL ELEMENTS
Model
108-L-9595
Device description
Overwatch 9.5MM x 95MM Low Top Pedicle Screw
Published
2017-07-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916130602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916130602008409161306028409161306020840916130602

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
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536162109neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGKWP2026-06-08
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082055ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082062ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082079ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082086ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082093ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
M711BTA2020Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
M711LS7490Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04