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Ascension®

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Ascension® FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes five silicone MCP trials to evaluate the size and fit of the implants. FDA UDI
Model / Reference
SILMCPINSTP FDA UDI
Description
The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes five silicone MCP trials to evaluate the size and fit of the implants. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780237464 FDA UDI
510(k) Number
K022892 FDA UDI
FDA Product Code
KYJ FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3230 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Ascension® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K022892 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 5fffe724-a612-45a7-9e44-f0752ffa8734 37 fields · synced May 31, 2026