Identity
- Trade Name
- 12mm STEP STAPLE 15X20-2X2 FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Model / Reference
- 17717 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209177170 FDA UDI
- 510(k) Number
- K061798 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone staple, non-adjustable
12mm STEP STAPLE 15X20-2X2 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable.
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- Elite — Synthes · Class II
- MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Speed Arc — Synthes · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
Cleared under the same submission
K061798 also covers:
- 9mm STEP STAPLE 15X20-2X2 — BIOPRO, INC.
- ANCHOR PIN — BIOPRO, INC.
- ANGLED STAPLE PUNCH — BIOPRO, INC.
- Anchor Pin — BIOPRO, INC.
- BIOPRO MEMORY STAPLE 13X15-1.5X1.5MM PKG — BIOPRO, INC.
- DRILL GUIDE 15 18MM — BIOPRO, INC.
- DRILL GUIDE 7 9MM — BIOPRO, INC.
- DRILL GUIDE ADJUSTABLE — BIOPRO, INC.
- Drill Guide 7 - 9MM — BIOPRO, INC.
- Drill Guide Single Hole — BIOPRO, INC.
- LARGE STAPLE 30x30 — BIOPRO, INC.
- LARGE STAPLE CLAMP — BIOPRO, INC.
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
- Biopro, Inc.
Sources (1)
- FDA UDI 9c8bfd43-f842-4a8f-9d7f-5b64eb74559b 34 fields · synced May 30, 2026