Identity
- Trade Name
- BIO-STINGER FDA UDI
- Generic Name
- Meniscus screw FDA UDI
- Device Name
- BIO-STINGER-V BIOABSORBABLE 16MM TINTED WITH D&C VIOLET NO. 2 FDA UDI
- Model / Reference
- V8216 FDA UDI
- Description
- BIO-STINGER-V BIOABSORBABLE 16MM TINTED WITH D&C VIOLET NO. 2 FDA UDI
Identifiers
- Catalog Number
- V8216 FDA UDI
- Primary DI / UDI-DI
- 20845854014018 FDA UDI
- 510(k) Number
- K991715 FDA UDI
- FDA Product Code
- MAI FDA UDI
- GMDN Term
- Meniscus screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Millimeter FDA UDIOuter Diameter — 16 Millimeter FDA UDI
Category: Meniscus screw
Bio-Stinger by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Meniscus screw.
- BioTritis — Covidien LP · Class II
- BioTritis — Covidien LP · Class I
- CONTOUR MENISCUS ARROW — Conmed Corporation · Class II
- BIO-STINGER — Conmed Corporation · Class II
- HORNET BIOSTINGER — Conmed Corporation · Class II
- HORNET BIOSTINGER — Conmed Corporation · Class II
- CONTOUR MENISCUS ARROW — Conmed Corporation · Class II
- HORNET BIOSTINGER — Conmed Corporation · Class II
Cleared under the same submission
K991715 also covers:
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 |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI cd070e35-c256-491b-a657-eb0fcbf4185c 37 fields · synced May 30, 2026