Identity
- Trade Name
- SCREW PICK UP 1.5 2.7 FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Model / Reference
- 18334 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810012485210 FDA UDI
- 510(k) Number
- K083490 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use 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
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic inorganic implant inserter/extractor, single-use
This manual surgical instrument, the SCREW PICK UP 1.5 2.7, is a hand-held orthopedic medical device designed for the insertion and extraction of non-tissue-based (inorganic) orthopaedic implants, such as bone nails or spiral blades. It features a one-piece or modular configuration with a locking region that attaches to part of the implant, providing a secure fit. The instrument includes two mechanisms: a striking force application mechanism on a pad/flange and a twisting screw mechanism, allowing for precise control during insertion and extraction.
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.
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Cleared under the same submission
K083490 also covers:
- 4" NON THREADED SNGL TROCHAR WIRE .035 — BIOPRO, INC.
- 4" NON THREADED SNGL TROCHAR WIRE .045 — BIOPRO, INC.
- 4" NON THREADED SNGL TROCHAR WIRE .062 — BIOPRO, INC.
- 4" THREADED K-WIRE .045 — BIOPRO, INC.
- 4" THREADED K-WIRE .062 — BIOPRO, INC.
- 5" POINTED BONE CLAMP — BIOPRO, INC.
- 6" BONE CLAMP — BIOPRO, INC.
- BioPro Kwire .062" Sterile Packed — BIOPRO, INC.
- CANNULATED DRILL (6.5) — BIOPRO, INC.
- CANNULATED DRILL 2.02.5MM — BIOPRO, INC.
- CANNULATED DRILL 3.03.5MM — BIOPRO, INC.
- CANNULATED DRILL 4.04.5MM — BIOPRO, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
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 5a0a6925-56bf-47c6-93f4-73c460296fb4 33 fields · synced Jul 27, 2026