FDA.report

Swedge Pedicle Screw Fixation System

Primary DI
B515RSCT55250
Brand
Swedge Pedicle Screw Fixation System
Company
SPINAL RESOURCES, INC.
Model
RSCT55-25
Device description
Rod, Standard, Curved, Titanium, 5.5mm x 25mm
Published
2018-03-12
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K170045000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K170045000Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.2017-06-26NKB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B515RSCT55250PrimaryHIBCC0

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
018255727
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
true
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

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B515RSTT47555500Swedge Pedicle Screw Fixation SystemRSTT47555-5002024-12-25
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B515RSCTT47555120Swedge Pedicle Screw Fixation SystemRSCTT47555-1202024-07-29
B515RSCTT47555140Swedge Pedicle Screw Fixation SystemRSCTT47555-1402024-07-29
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B515SPSCT6550Swedge Pedicle Screw Fixation SystemSPSCT65502024-07-29
B515LC030Swedge Pedicle Screw Fixation SystemLC-032020-06-08
B515LC040Swedge Pedicle Screw Fixation SystemLC-042020-06-08
B515RSTT47555060Swedge Pedicle Screw Fixation SystemRSTT47555-0602024-02-09
B515RSTT47555070Swedge Pedicle Screw Fixation SystemRSTT47555-0702024-02-09
B515RSTT47555080Swedge Pedicle Screw Fixation SystemRSTT47555-0802024-02-09
B515RSTT47555090Swedge Pedicle Screw Fixation SystemRSTT47555-0902024-02-09
B515RSTT47555100Swedge Pedicle Screw Fixation SystemRSTT47555-1002024-02-09
B515RSTT47555120Swedge Pedicle Screw Fixation SystemRSTT47555-1202024-06-12
B515RSTT47555250Swedge Pedicle Screw Fixation SystemRSTT47555-2502024-06-12
B515RSCTT47555110Swedge Pedicle Screw Fixation SystemRSCTT47555-1102024-05-20
B515RSCTT47555130Swedge Pedicle Screw Fixation SystemRSCTT47555-1302024-05-20
B515RSCTT47555150Swedge Pedicle Screw Fixation SystemRSCTT47555-1502024-05-20
B515RSTT47555110Swedge Pedicle Screw Fixation SystemRSCTT47555-1102024-05-20

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