FDA.report

Cortera

Primary DI
00840311209453
Brand
Cortera
Company
Xtant Medical Holdings, Inc.
Model
1505-003120
Device description
Dilator, MIS, Screw
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840311209453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311209453008403112094538403112094530840311209453

GMDN Terms

TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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

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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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