FDA.reportPublic FDA data

Optio-C®

Primary DI
00889024330337
Brand
Optio-C®
Company
ZIMMER SPINE, INC.
Model
07.01879.047
Catalog number
07.01879.047
Published
2016-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024330337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024330337008890243303378890243303370889024330337

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)774-6368zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
787663400
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024333499Minit®300-4018300-40182015-09-24
00889024334977Sequoia®3306-55503306-55502015-09-24
00889024335004Sequoia®3306-65303306-65302015-09-24
00889024335059Sequoia®3306-65553306-65552015-09-24
00889024335134Sequoia®3306-75603306-75602015-09-24
00889024335165Sequoia®3306-85403306-85402015-09-24
00889024335486Sequoia®3361-0553361-0552016-06-23
00889024331419InFix® Anterior Lumbar System1850-51121850-51122016-06-23
00889024331426InFix® Anterior Lumbar System1850-51141850-51142016-06-23
00889024331433InFix® Anterior Lumbar System1850-53081850-53082016-06-23
00889024331440InFix® Anterior Lumbar System1850-53141850-53142016-06-23
00889024331457InFix® Anterior Lumbar System1850-55081850-55082016-06-23
00889024331464InFix® Anterior Lumbar System1850-55121850-55122016-06-23
00889024402577InFix® Anterior Lumbar System1850-51001850-51002016-06-23
00889024402584InFix® Anterior Lumbar System1850-51081850-51082016-06-23
00889024402591InFix® Anterior Lumbar System1850-51101850-51102016-06-23
00889024402607InFix® Anterior Lumbar System1850-53101850-53102016-06-23
00889024402614InFix® Anterior Lumbar System1850-53121850-53122016-06-23
00889024402621InFix® Anterior Lumbar System1850-55101850-55102016-06-23
00889024402638InFix® Anterior Lumbar System1850-55141850-55142016-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810056992743aprevoCarlsmed, Inc.OVE2026-03-17
00810056992804aprevoCarlsmed, Inc.OVE2026-03-17
00810056992866aprevoCarlsmed, Inc.OVE2026-03-17
00810056992958aprevoCarlsmed, Inc.OVE2026-03-17
00763000880422Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.OVE2026-03-02
10195860030407E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030414E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030469E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030476E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030483E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030490E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030513E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030520E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030544E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030629E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030636E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030643E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030650E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030667E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030681E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030698E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030711E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030735E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030759E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030773E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030797E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030865E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030872E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030902E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030933E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20