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Lupine Orthocord

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name
LUPINE ORTHOCORD FDA UDI
Generic Name
Tendon/ligament bone anchor, bioabsorbable FDA UDI
Device Name
LUPINE LOOP ANCHOR Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Suture, 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop. FDA UDI
Model / Reference
222980 FDA UDI
Description
LUPINE LOOP ANCHOR Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Suture, 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop. FDA UDI

Identifiers

Catalog Number
222980 FDA UDI
Primary DI / UDI-DI
10886705008582 FDA UDI
510(k) Number
K040827 FDA UDI
FDA Product Code
GAM FDA UDI
MAI FDA UDI
GMDN Term
Tendon/ligament bone anchor, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Lupine Orthocord by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K040827 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DePuy Mitek, Inc.

Sources (1)

  • FDA UDI 5115c24d-20fa-4134-aee1-db21d84f1c87 38 fields · synced Jun 1, 2026