FDA.report

Cypher™ MIS System

Primary DI
00888480502012
Brand
Cypher™ MIS System
Company
BIOMET SPINE LLC
Model
14-571201
Catalog number
14-571201
Published
2020-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications

CodeDeviceSpecialtyClass
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888480502012PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags

DUNS number
018577570
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 DIBrandModelCatalogPublished
03662663063234Vital Spinal Fixation System727M54002024-05-10
03662663063241Vital Spinal Fixation System727M55102024-05-10
03662663063258Vital Spinal Fixation System727M64002024-05-10
03662663063265Vital Spinal Fixation System727M65102024-05-10
03662663063272Vital Spinal Fixation System727M74002024-05-10
03662663063289Vital Spinal Fixation System727M75102024-05-10
03662663063296Vital Spinal Fixation System727M84002024-05-10
03662663063302Vital Spinal Fixation System727M85102024-05-10
03662663063524Vital Spinal Fixation System727M54012024-05-10
03662663063531Vital Spinal Fixation System727M54022024-05-10
03662663063548Vital Spinal Fixation System727M55112024-05-10
03662663063555Vital Spinal Fixation System727M55122024-05-10
03662663063562Vital Spinal Fixation System727M64012024-05-10
03662663063579Vital Spinal Fixation System727M64022024-05-10
03662663063586Vital Spinal Fixation System727M65112024-05-10
03662663063593Vital Spinal Fixation System727M65122024-05-10
03662663063609Vital Spinal Fixation System727M74012024-05-10
03662663063616Vital Spinal Fixation System727M74022024-05-10
03662663063623Vital Spinal Fixation System727M75112024-05-10
03662663063630Vital Spinal Fixation System727M75122024-05-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000794675CD HORIZON ESSENCE™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-08-14
00763000788018CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-07-10
00763000787837CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-06-14
00763000788001CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-15
00763000787813CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-04
00763000872236CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2025-05-03
00840314178336Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178343Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178350Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178367Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178374Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178381Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178398Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178404Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178411Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178428Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178435Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178442Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178459Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178466Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178473Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178480Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178497Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178503Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178510Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178527Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178534Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178541Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178558Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18
00840314178565Nex-D2NEXT ORTHOSURGICAL, INC.OSH2025-04-18