Identity
- Trade Name
- Lapidus Plate Trials FDA UDI
- Generic Name
- Surgical instrument/implant depth limiter, reusable FDA UDI
- Device Name
- surgical instrument or accessory for orthopedic bone fixation FDA UDI
- Model / Reference
- FIS 622 FDA UDI
- Description
- surgical instrument or accessory for orthopedic bone fixation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840118111966 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical instrument/implant depth limiter, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument/implant depth limiter, reusable
Lapidus Plate Trials by Flower Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/implant depth limiter, reusable.
- Drill Stop — Oco Biomedical · Class I
- NOBEL SELECT MARKING PIN LONG 3.6mm X 27mm — W.H. Holden, Inc. · Class I
- Leith Medical Plating System Instruments — Leith Medical LLC · Class II
- EV ASTRA PIN - EV 1.9mm X 24mm — W.H. Holden, Inc. · Class I
- MemoFix Super Elastic Nitinol Staple System — Smith & Nephew, Inc. · Class I
- Drill Stop for Pilot Drill — Oco Biomedical · Class I
- MAS PLIF — Nuvasive, Inc. · Class I
- AXIOM® — ETABLISSEMENTS ANTHOGYR · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Flower Orthopedics Corporation
Sources (1)
- FDA UDI e98ab17f-fb17-4d35-b847-05d1f423a5c5 33 fields · synced May 30, 2026