Identity
- Trade Name
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- GLENOID DRILL MASK WITH CENTRAL PEG STD RIGHT FOR 3PEGS FDA UDI
- Model / Reference
- GLENOID DRILL MASK FDA UDI
- Description
- GLENOID DRILL MASK WITH CENTRAL PEG STD RIGHT FOR 3PEGS FDA UDI
Identifiers
- Catalog Number
- 9C13.79.110 FDA UDI
- Primary DI / UDI-DI
- 08033390105958 FDA UDI
- 510(k) Number
- K130642 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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: Surgical drill guide, reusable
Glenoid Drill Mask With Central Peg For 3pegs by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Cleared under the same submission
K130642 also covers:
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS — Limacorporate
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS — Limacorporate
- GLENOID DRILL MASK WITH CENTRAL PEG FOR 3PEGS — Limacorporate
- SMR SHOULDER — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
- SMR Shoulder — Limacorporate
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Limacorporate
Sources (1)
- FDA UDI 350087b0-6a73-4d86-ae79-303dcb7787a2 36 fields · synced May 30, 2026