FDA.reportPublic FDA data

OVERWATCH

Primary DI
00840606171458
Brand
OVERWATCH
Company
SPINAL ELEMENTS, INC.
Model
108-ET-8560
Device description
8.5MM X 60MM OVERWATCH® EXTENDED TAB SOLID SCREW
Published
2022-05-04
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
00840606171458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606171458008406061714588406061714580840606171458

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
610712213
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
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
06941312465757Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465771Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465788Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465795Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465801Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465818Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465825Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465832Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465849Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465856Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465887Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465894Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465900Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465559Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22