Wire, Surgical
Surgical wire is a metal wire used in orthopedic and surgical procedures for the fixation, cerclage, or securing of bone fragments, prosthetic components, or soft tissues during operative intervention. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LRN, regulated under 21 CFR 888.3030, within the Orthopedic medical specialty. This device carries the implant flag, as it is typically placed and retained within the body after surgery.
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Basic Information
- Product Code
- LRN
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | Dec 04, 2000 | Substantially Equivalent | T. Korossurgical Instruments Corp. |
| K990355 | STAINLESS STEEL SOFT SUTURE WIRE | Jul 08, 1999 | Substantially Equivalent | Bregma International Trading Company , Ltd. |
| K971682 | J-FX CERCLAGE SYSTEM | Jun 27, 1997 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K952783 | OXBORO-MEDICAL PIN COVERS | Sep 15, 1995 | Substantially Equivalent | Oxboro Medical Intl., Inc. |
| K942603 | ORTHOPAEDIC WIRES | Nov 09, 1994 | Substantially Equivalent | Acu Med, Inc. |
| K900926 | TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) | Apr 23, 1990 | Substantially Equivalent | Howmedica Corp. |
| K892651 | SONGER WIRING SYSTEM | Jul 25, 1989 | Substantially Equivalent | Danek Medical, Inc. |
| K864375 | TYPE 316L COTTER WIRE | May 20, 1987 | Substantially Equivalent for Some Indications | Winn Hirsch & Assoc. |
FEI Numbers
This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.