FDA.reportPublic FDA data

InCompass®

Primary DI
00889024400337
Brand
InCompass®
Company
ZIMMER SPINE, INC.
Model
2204-11N-SB
Catalog number
2204-11N-SB
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024400337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024400337008890244003378890244003370889024400337

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024399006SlimLine®403-4072403-40722015-09-25
00889024403741SlimLine®403-4068403-40682019-12-02
00889024403758SlimLine®403-4076403-40762019-12-02
00889024403765SlimLine®403-4080403-40802019-12-02
00889024403772SlimLine®403-4084403-40842019-12-02
00889024403789SlimLine®403-4088403-40882019-12-02
00889024403796SlimLine®403-4092403-40922019-12-02
00889024404083SlimLine®403-4168403-41682019-12-02
00889024404090SlimLine®403-4172403-41722019-12-02
00889024404106SlimLine®403-4176403-41762019-12-02
00889024404113SlimLine®403-4180403-41802019-12-02
00889024404120SlimLine®403-4184403-41842019-12-02
00889024404137SlimLine®403-4188403-41882019-12-02
00889024404144SlimLine®403-4192403-41922019-12-02
00889024404151SlimLine®404-2036404-20362019-11-17
00889024404168SlimLine®404-2040404-20402019-11-17
00889024404175SlimLine®404-2042404-20422019-11-17
00889024404182SlimLine®404-2044404-20442019-11-17
00889024404199SlimLine®404-2046404-20462019-11-17
00889024404205SlimLine®404-2048404-20482019-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNI2026-05-25
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00841732117860PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117877PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117884PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117891PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117907PICASSO IICTL Medical CorporationMNI2023-09-07
00841732117914PICASSO IICTL Medical CorporationMNI2023-09-07
00841732118959PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118966PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118973PICASSO IICTL Medical CorporationMNI2017-08-08
00841732118980PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119017PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119024PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119031PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119048PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119055PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119062PICASSO IICTL Medical CorporationMNI2017-08-08
00841732119079PICASSO IICTL Medical CorporationMNI2017-08-08
088000333846944CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNI2015-12-11