Identity
- Trade Name
- Romero Finishing Impactor FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Romero Finishing Impactor FDA UDI
- Model / Reference
- RO0027FIZZ FDA UDI
- Description
- Romero Finishing Impactor FDA UDI
Identifiers
- Catalog Number
- RO0027FIZZ FDA UDI
- Primary DI / UDI-DI
- B806RO0027FIZZ0 FDA UDI
- FDA Product Code
- HWA FDA UDI
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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 impactor, reusable
Romero Finishing Impactor by Spineup, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant impactor, reusable.
- TRIAL COVERING INSERT Ø32 48 — groupe lépine · Class IIa
- MobiliT Cup — CORIN LTD · Class II
- R3 — Smith & Nephew, Inc. · Class II
- TRIAL COVERING INSERT Ø28 39 — groupe lépine · Class IIa
- MobiliT Cup — CORIN LTD · Class II
- KMEDIC — TELEFLEX INCORPORATED · Class I
- TRIAL COVER INSERT Ø28 36 — groupe lépine · Class IIa
- R3 — Smith & Nephew, Inc. · 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
- Spineup, Inc.
Sources (1)
- FDA UDI fbd800c0-5cfa-4687-a0f2-5e094259f85a 35 fields · synced Jun 8, 2026