FDA.reportPublic FDA data

OPTIMUS

Primary DI
00840916129354
Brand
OPTIMUS
Company
SPINAL ELEMENTS
Model
135032
Device description
Optimus Screw 32mm
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916129354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916129354008409161293548409161293540840916129354

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
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
00197157074050ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074067ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074074ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074081ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074098ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074104ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074111ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074128ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074135ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074142ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074159ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074166ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074173ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074180ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074197ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074203ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074210ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074227ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074234ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074241ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074258ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074265ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074272ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074289ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074296ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074302ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074319ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074326ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074333ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074340ZAVATION SCREWZavation LLCOVD2026-05-29