FDA.report

F1 MPS Modular Pedicle Screw System

Primary DI
00842048116554
Brand
F1 MPS Modular Pedicle Screw System
Company
DEGEN MEDICAL, INC.
Model
0122-55045
Catalog number
0122-55045
Device description
Rod, Straight, MIS, 5.5 X 45, CoCr
Published
2018-04-16
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

Contact Domains

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
00842048116554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842048116554008420481165548420481165540842048116554

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
Outer Diameter5.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)240-7838customerservice@degenmedical.com

Regulatory Flags

DUNS number
078812602
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

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00842048183365Latitude-C AM™ Cervical Interbody Fusion System0306-121209L080306-121209L082025-11-24

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