← Back to catalogue

Lupine Panacryl

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name
LUPINE PANACRYL FDA UDI
Generic Name
Tendon/ligament bone anchor, bioabsorbable FDA UDI
Device Name
LUPINE LOOP PLUS ANCHOR w/PANACRYL PLA Absorbable Anchor, size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91cm). Size 1 (4 metric) PANACRYL eyelet loop. FDA UDI
Model / Reference
210707 FDA UDI
Description
LUPINE LOOP PLUS ANCHOR w/PANACRYL PLA Absorbable Anchor, size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91cm). Size 1 (4 metric) PANACRYL eyelet loop. FDA UDI

Identifiers

Catalog Number
210707 FDA UDI
Primary DI / UDI-DI
10886705001057 FDA UDI
510(k) Number
K062170 FDA UDI
FDA Product Code
MAI FDA UDI
JDR FDA UDI
HWC FDA UDI
GMDN Term
Tendon/ligament bone anchor, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 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 Panacryl by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K062170 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
DePuy Mitek, Inc.

Sources (1)

  • FDA UDI a493def1-216b-4212-9fd2-f0b99cb23c6a 37 fields · synced Jun 8, 2026