Spirit

FDA UDI

Class II (US FDA UDI)

by Responsive Orthopedics Llc

Identity

Trade Name: Spirit FDA UDI
Generic Name: Ligament bone anchor FDA UDI
Device Name: Spirit PEEK 09 x 28 FDA UDI
Model / Reference: 90-RAC-310928 FDA UDI
Description: Spirit PEEK 09 x 28 FDA UDI

Identifiers

Primary DI / UDI-DI: 00811714031026 FDA UDI
510(k) Number: K180573 FDA UDI
FDA Product Code: MBI FDA UDI
HWC FDA UDI
GMDN Term: Ligament bone anchor 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ligament bone anchor

Spirit by Responsive Orthopedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ligament bone anchor.

EZLOC — Biomet Sports Medicine · Class II
MINI BONE MULCH — Biomet Sports Medicine · Class II
EZLOC™ — Biomet Orthopedics, Inc. · Class II
JUGGERKNOT — Biomet Orthopedics, Inc. · Class II
M-ARS ACL: Anatomic Ribbon Surgery System — Medacta International · Class II
TITANIUM INTERFERENCE SCREW — Biomet Sports Medicine · Class II
AXL CROSSPIN — Biomet Sports Medicine · Class II
Corifix Ligament Anchor Screw — CORIN LTD · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Responsive Orthopedics Llc

Sources (1)

FDA UDI 64704c20-6a1a-45b0-b5a2-82dc370e957c 34 fields · synced Jun 8, 2026