FDA.reportPublic FDA data

PressON™

Primary DI
B6788203610
Brand
PressON™
Company
NEXUS SPINE, L.L.C.
Model
820361
Device description
Rivet Deploy Shaft
Published
2022-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133287000PRESSON SPINAL FIXATION SYSTEMNexus Spine, LLC2014-02-25MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678820361Direct MarkingHIBCC0
B6788203610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
028137605
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785209110PressON Pedicle Screw System5209112026-09-04
B6785209120PressON Pedicle Screw System5209122026-09-04
B6785209130PressON Pedicle Screw System5209132026-09-04
B6785209140PressON Pedicle Screw System5209142026-09-04
B6785209150PressON Pedicle Screw System5209152026-09-04
B6785209160PressON Pedicle Screw System5209162026-09-04
B6785209170PressON Pedicle Screw System5209172026-09-04
B6785209180PressON Pedicle Screw System5209182026-09-04
B6785209190PressON Pedicle Screw System5209192026-09-04
B6785209200PressON Pedicle Screw System5209202026-09-04
B6785209210PressON Pedicle Screw System5209212026-09-04
B6785209220PressON Pedicle Screw System5209222026-09-04
B6785209230PressON Pedicle Screw System5209232026-09-04
B6785209240PressON Pedicle Screw System5209242026-09-04
B6785209250PressON Pedicle Screw System5209252026-09-04
B6785209260PressON Pedicle Screw System5209262026-09-04
B6785209270PressON Pedicle Screw System5209272026-09-04
B6785209280PressON Pedicle Screw System5209282026-09-04
B6785209290PressON Pedicle Screw System5209292026-09-04
B6785209300PressON Pedicle Screw System5209302026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
00885556824757DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.LXH2023-02-10
00885556864609Titan Reverse Shoulder SystemSmith & Nephew, Inc.LXH2023-02-02
00885556864616Titan Reverse Shoulder SystemSmith & Nephew, Inc.LXH2023-02-02
00885556865132Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.LXH2023-01-19
00885556865514Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.LXH2023-01-19
00885556865460Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.LXH2023-01-19
00885556835029Ti6 Internal Fixation SystemSmith & Nephew, Inc.LXH2022-12-22
00885556835203Surgical InstrumentsSmith & Nephew, Inc.LXH2022-12-22
00885556854921Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.LXH2022-12-22
00885556863688Titan Reverse Shoulder SystemSmith & Nephew, Inc.LXH2022-12-22
00885556868997Kompressor Compression Screw SystemSmith & Nephew, Inc.LXH2022-12-22
00885556841631XT Revision Ankle Replacement SystemSmith & Nephew, Inc.LXH2022-12-21
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCMNI2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCMNI2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24