FDA.reportPublic FDA data

Apex

Primary DI
05391529581633
Brand
Apex
Company
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model
INS-1134
Catalog number
INS-1134
Device description
Apex Tibial Nailing System Kit
Published
2022-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170972000Apex Tibial Nailing SystemOrthoxel2017-12-20HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391529581633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391529581633053915295816335391529581633

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00ambient storage and handling

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
646-661-3167CUSTOMERCARE@ORTHOXEL.COM

Regulatory Flags#

DUNS number
985596830
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391529588502ApexE04-020E04-0202022-08-17
05391529582128ApexE02-000E02-0002022-08-10
05391529582135ApexE02-005E02-0052022-08-10
05391529582142ApexE02-010E02-0102022-08-10
05391529582159ApexE02-015E02-0152022-08-10
05391529582166ApexE02-020E02-0202022-08-10
05391529582173ApexLE02-000LE02-0002022-08-10
05391529588465ApexE04-000E04-0002022-02-23
05391529588472ApexE04-005E04-0052022-02-23
05391529588489ApexE04-010E04-0102022-02-23
05391529588496ApexE04-015E04-0152022-02-23
05391529588519ApexLE04-000LE04-0002022-02-23
05391529585099ApexE03-000E03-0002021-02-05
05391529585105ApexE03-005E03-0052021-02-05
05391529585112ApexE03-010E03-0102021-02-05
05391529585129ApexE03-015E03-0152021-02-05
05391529585136ApexLE03-000LE03-0002021-02-05
05391529580773ApexE01-0052019-10-01
05391529580780ApexE01-0102019-10-01
05391529580797ApexE01-0152019-10-01

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Primary DI, Brand, Company table
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00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
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20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
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B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03