Identity
- Trade Name
- Memory Staple Instrument Tray FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Model / Reference
- 17708 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209177080 FDA UDI
- 510(k) Number
- K061798 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Memory Staple Instrument Tray by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
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- Knee Instruments — Medacta International · Class I
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- Hip Instruments — Medacta International · Class I
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
Cleared under the same submission
K061798 also covers:
- 12mm STEP STAPLE 15X20-2X2 — BIOPRO, INC.
- 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.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI c2619a50-0d68-4e44-95a8-dbba14253500 33 fields · synced May 31, 2026