FDA.report

Cortera

Primary DI
00840311208869
Brand
Cortera
Company
Xtant Medical Holdings, Inc.
Model
1505-001880
Device description
Rod Caliper, MIS
Published
2023-01-20
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

Related Records

Contact Domains

Product Codes

CodeName
KTZCALIPER

Product Code Classifications

CodeDeviceSpecialtyClass
KTZCaliperOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840311208869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311208869008403112088698403112088690840311208869

GMDN Terms

TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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

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03662663244701Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
03662663244800Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
00887868457180Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
00888480500834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663131957Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663194020PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663194037PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663126137Vital Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-07
00763000684112N/AMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-09-08
00194613115111MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-08-01
00190376585628InvictusALPHATEC SPINE, INC.KTZ2025-05-01
04719886908275USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KTZ2025-04-30
00194613050023MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00194613081515MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00763000864675n/aMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-03-11
09421028119290Kinematic Alignment Caliper – S+NENZTEC LIMITEDKTZ2025-01-24
00840343724863GEN2SURGIX MEDICAL LLCKTZ2025-01-13
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