FDA.report

MESA® Small Stature Spinal System

Primary DI
10888857052529
Brand
MESA® Small Stature Spinal System
Company
K2M, INC.
Model
3001-84560HV
Catalog number
3001-84560HV
Device description
Axial Connector
Published
2015-09-24
Public version status
Update
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
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888857052529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088885705252910888857052529

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
Length60Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(703)777-3155mzellers@k2m.com
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags

DUNS number
146060863
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

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10888857596993K2M General InstrumentsPRO-1002-04PRO-1002-042026-03-24
10888857580022LITe® Pedicle Based RetractorPRO-1388-01PRO-1388-012026-03-04
10888857580039LITe® Pedicle Based RetractorPRO-1388-02PRO-1388-022026-03-04
10888857580046LITe® Pedicle Based RetractorPRO-1388-03PRO-1388-032026-03-04
10888857580053LITe® Pedicle Based RetractorPRO-1388-04PRO-1388-042026-03-04
10888857580060LITe® Pedicle Based RetractorPRO-1388-05PRO-1388-052026-03-04
10888857580077LITe® Pedicle Based RetractorPRO-1388-06PRO-1388-062026-03-04
10888857580084LITe® Pedicle Based RetractorPRO-1388-07PRO-1388-072026-03-04
10888857563384Q Interbody Instruments8020-900208020-900202026-03-03
10888857563391Q Interbody Instruments8020-900218020-900212026-03-03
10888857563407Q Interbody Instruments8020-900228020-900222026-03-03
10888857563414Q Interbody Instruments8020-900238020-900232026-03-03
10888857563421Q Interbody Instruments8020-900248020-900242026-03-03
10888857563650Q Interbody Instruments8020-900868020-900862026-03-03
10888857574700Q Interbody Instruments8020-90092-GS8020-90092-GS2026-03-03
10888857578715Q Interbody Instruments8020-100018020-100012026-03-03
10888857578722Q Interbody Instruments8020-100028020-100022026-03-03
10888857578739Q Interbody Instruments8020-100038020-100032026-03-03
10888857578876Q Interbody Instruments8020-900258020-900252026-03-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
06941312465757Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
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06941312465894Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465900Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465559Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
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06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22