FDA.reportPublic FDA data

PANALOK ORTHOCORD

Primary DI
10886705000791
Brand
PANALOK ORTHOCORD
Company
DEPUY MITEK, LLC
Model
210024
Catalog number
210024
Device description
PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm), double-armed with (2) CP-2 needles, with disposable inserter.
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705000791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500079110886705000791

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705011049STRAIGHTSHOT2322152322152015-09-01
10886705011056STRAIGHTSHOT2322202322202015-09-01
10886705017836BRISTOW LATARJET2851802851802015-09-01
10886705022533BRISTOW LATARJET2851432851432015-09-01
10886705004980VERSALOK2154402154402015-09-01
10886705018178BRISTOW LATARJET2853452853452015-09-01
10886705025213EXPRESSEW2141592141592017-03-17
10886705002528QUICKANCHOR ETHIBOND TAPERCUT2128652128652015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705008223FASTIN ETHIBOND2227202227202015-09-01
10886705017454FMS2845492845492017-03-17
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023462HEALIX ADVANCE2223302223302015-09-01
10886705023479HEALIX ADVANCE2223312223312015-09-01
10886705023493HEALIX ADVANCE2223322223322015-09-01
10886705010684MILAGRO2318002318002015-09-01
10886705010738MILAGRO2318052318052015-09-01
10886705010776MILAGRO2318102318102015-09-01
10886705010783MILAGRO2318152318152015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816537023012FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHMAI2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHMAI2025-10-01
07613327662016KNOTILUS+STRYKER CORPORATIONMAI2025-06-16
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCMAI2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
07613327547429DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547436DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547443DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547450DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547467DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
10845854045794CROSSFT, HI-FIConmed CorporationMAI2024-04-18
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHMAI2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHMAI2024-04-12