Identity
- Trade Name
- Open Knot Pusher FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Model / Reference
- 902803 FDA UDI
Identifiers
- Catalog Number
- 902803 FDA UDI
- Primary DI / UDI-DI
- 00887868567483 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant driver
Open Knot Pusher by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant driver.
- VYRSA General Instrument — Vyrsa Technologies · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Daytona — SeaSpine Orthopedics Corporation · Class I
- Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
- NewPort — SeaSpine Orthopedics Corporation · Class I
- Hex Driver — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- T8 Driver 200mm AO QC — Zimmer, Inc. · Class I
- CoLink — In2Bones, USA · 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI cc1b7b1e-7286-4fc5-8808-04895ef436a9 34 fields · synced May 30, 2026