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STRoPP

FDA UDI

Class II (US FDA UDI)

by Crossroads Extremity Systems Llc

Identity

Trade Name
STRoPP FDA UDI
Generic Name
Suturing needle holder, single-use FDA UDI
Device Name
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs. FDA UDI
Model / Reference
STRoPP Plantar Plate Repair Kit - Sterile FDA UDI
Description
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs. FDA UDI

Identifiers

Catalog Number
1601-0000 FDA UDI
Primary DI / UDI-DI
00815432023097 FDA UDI
FDA Product Code
MBI FDA UDI
GMDN Term
Suturing needle holder, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Suturing needle holder, reusableOrthopaedic inorganic implant inserter/extractor, reusableTendon/ligament bone anchor, non-bioabsorbableOrthopaedic surgical distractor, internal

STRoPP by Crossroads Extremity Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-resection orthopaedic reamer, reprocessed.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Crossroads Extremity Systems Llc

Sources (1)

  • FDA UDI 0fbe7eda-3125-4cd0-bad7-eae1c9130cb2 36 fields · synced May 30, 2026