FDA.reportPublic FDA data

Deploy™ Expandable Interbody System

Primary DI
00815351022669
Brand
Deploy™ Expandable Interbody System
Company
Southern Spine LLC
Model
BT-1239
Device description
Luer Lock Graft Cannula
Published
2022-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211845000Deploy Expandable Interbody SystemSouthern Spine, LLC2021-11-16MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815351022669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815351022669008153510226698153510226690815351022669

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft inserterA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(478)330-6205donna@t3med.com

Regulatory Flags#

DUNS number
794672225
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815351022683Deploy™ Expandable Interbody SystemDT-12442022-01-10
00815351020009Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10212015-10-16
00815351020016Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10242015-10-16
00815351020023Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10272015-10-16
00815351020030Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10302015-10-16
00815351020047Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System10332015-10-16
00815351020054Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20362015-10-16
00815351020061Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20392015-10-16
00815351020078Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20422015-10-16
00815351020085Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20452015-10-16
00815351020092Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System20482015-10-16
00815351020108Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30542015-10-16
00815351020115Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30582015-10-16
00815351020122Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30622015-10-16
00815351020139Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30662015-10-16
00815351020146Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System30702015-10-16
00815351020153Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40722015-10-16
00815351020160Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40762015-10-16
00815351020177Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40802015-10-16
00815351020184Anterior Cervical Stabilization System (SSACSS), Kwik-Fix® Cervical System40842015-10-16

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