FDA.reportPublic FDA data

Cortera

Primary DI
00840311208920
Brand
Cortera
Company
Xtant Medical Holdings, Inc.
Model
1505-001930
Device description
Driver, Rod Inserter, MIS, 90Deg, MT
Published
2023-01-06
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311208920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311208920008403112089208403112089200840311208920

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant handling forcepsA hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
false
Premarket exempt
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311262854CONTACT ALPC999-0000122026-03-20
00840311233007CONTACT ALP Anterior Lumbar Plate System25-PUSHPIN25-PUSHPIN2025-10-02
00840311233014CONTACT ALP Anterior Lumbar Plate System25-PUSHPIN-252025-10-02
M697X00310040Calix-C Cervical Interbody SpacerX003-10042026-03-10
M697X03422130Calix Lumbar Spinal Implant SystemX034-22132026-03-10
00840311262694CASE, OUTER, DOUBLE LEVEL434-2222026-02-11
00840311262700CASE, OUTER, LID 434-2242026-02-11
00840311247318Fortilink65-TC-INSERTER2026-01-22
00840311262670Cortera Spinal Fixation System1509-0300202025-12-22
00840311262687Cortera Spinal Fixation System1509-0400102025-12-22
00840311262663Streamline TL Spinal Fixation System02-PA-L-85CDY-E2025-12-17
00840311262632Fusion™ Posterior Instrument Set30-FUNNEL2025-12-11
00840311244713Cortera Spinal Fixation System1509-4000102025-12-10
00840311244720Cortera Spinal Fixation System1509-4000202025-12-10
00840311244737Cortera Spinal Fixation System1509-4000302025-12-10
00840311244744Cortera Spinal Fixation System1509-4000402025-12-10
00840311252237Cortera Spinal Fixation System1505-0017012025-11-20
00840311252244Cortera Spinal Fixation System1505-0017022025-11-20
00840311252251Cortera Spinal Fixation System1505-0017112025-11-20
00840311252268Cortera Spinal Fixation System1505-0017122025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766588420103Forceps - MagnifierCertified Safety Manufacturing, Inc.HTD2026-05-26
10766588420100Forceps - Magnifier UDI/10Certified Safety Manufacturing, Inc.HTD2026-05-26
00810143907537SURGIPROSSurgipros, LLCHTD2026-05-23
00190776417994MillenniumAvalign Technologies, Inc.HTD2026-03-23
24026704941494PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
24026704941500PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
00192896122857Diamond Head Grasping ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-19
00810158219267PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219274PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219045PRINCETONPrinceton Medical Group, Inc.HTD2026-03-11
00192896122741Micro Alligator ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
00192896122758Brophy Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
B382S1350010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382050Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382060Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382100Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382110Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S9057001000Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901132120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901186250Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD90118621C0Surgical DirectSurgical Direct, Inc.HTD2026-02-26