Identity
- Trade Name
- OvertureTi FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Model / Reference
- PKG-90-OSP-200017 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810129551754 FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, single-use FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 17.5 Millimeter FDA UDI
Category: Joint prosthesis implantation kit, single-use
OvertureTi by Overture Orthopaedics — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, single-use.
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
- Dekalb Knee Pack — PACKROOM LLC
- IDENTITY IMPRINT — Conformis, Inc. · Class II
- Argo Knotless — Conmed Corporation · Class IIa
- Instruments IIa — Newclip Technics SAS · Class IIa
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
- CC-Hook Right — Xiros Limited · Class IIa
- IDENTITY IMPRINT — Conformis, Inc. · 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Overture Orthopaedics
Sources (1)
- FDA UDI 54033bd0-87cb-4b6b-b25e-72bef794c56b 33 fields · synced May 30, 2026