J-Fx Cerclage System
FDA 510(k) K971682 · Johnson & Johnson Professionals, Inc.
510(k) numberK971682
Submission
- Device name
- J-Fx Cerclage System
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- May 6, 1997
- Decision date
- June 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRN – Wire, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K002755 | Non-Absorbing Sternatomy Monofilament SutureLRN · Traditional | T. Korossurgical Instruments Corp. | 12/04/2000SE |
| K990355 | Stainless Steel Soft Suture WireLRN · Traditional | Bregma International Trading Company , Ltd. | 07/08/1999SE |
| K952783 | Oxboro-Medical Pin CoversLRN · Traditional | Oxboro Medical Intl., Inc. | 09/15/1995SE |
| K942603 | Orthopaedic WiresLRN · Traditional | Acu Med, Inc. | 11/09/1994SE |
| K900926 | Trochanter Cable Grip System (Add'L Indications)LRN · Traditional | Howmedica Corp. | 04/23/1990SE |
| K892651 | Songer Wiring SystemLRN · Traditional | Danek Medical, Inc. | 07/25/1989SE |
| K864375 | Type 316L Cotter WireLRN · Traditional | Winn Hirsch & Assoc. | 05/20/1987SN |
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| K991222 | Codman Microsensor Ventricular Catheter KitGWM · Traditional | 07/09/1999SE |
| K982379 | Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional | 12/18/1998SE |
| K982812 | G2 Total Hip System Femoral Stem (11/13 Taper)KWY · Traditional | 12/04/1998SE |
| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | 11/06/1998SE |
| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
| K974739 | Hakim Programmable Valve SystemJXG · Traditional | 07/01/1998SE |
| K980801 | J-Fx Bipolar HeadKWY · Traditional | 05/29/1998SE |
Questions and answers
When was J-Fx Cerclage System cleared by the FDA?
J-Fx Cerclage System (K971682) received a 510(k) decision of Substantially Equivalent on June 27, 1997, 52 days after the submission was received.
What is the product code of K971682?
The FDA product code is LRN – Wire, Surgical, a Class II (moderate risk) device regulated under 21 CFR 888.3030.