Identity
- Trade Name
- SkyOPS FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Broach, Medial Bunion FDA UDI
- Model / Reference
- 001-1-01 FDA UDI
- Description
- Broach, Medial Bunion FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850024702370 FDA UDI
- FDA Product Code
- HTQ FDA UDI
- GMDN Term
- Orthopaedic broach 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic broach
SkyOPS by Sky Surgical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic broach.
- EcoFit® broach for short stem 133° — implantcast GmbH · Class I
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- Equinoxe — Exactech, Inc. · Class II
- Anthology — Smith & Nephew, Inc. · Class I
- Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- iNSitu™ Hip System — Nextstep Arthropedix · Class I
- TEMA Elbow — Limacorporate · Class II
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
- Sky Surgical
Sources (1)
- FDA UDI aaa409d4-5a98-4af6-85e0-fe57d0336c56 33 fields · synced May 30, 2026