Stainless Steel Soft Suture Wire
FDA 510(k) K990355 · Bregma International Trading Company , Ltd.
510(k) numberK990355
Submission
- Device name
- Stainless Steel Soft Suture Wire
- Applicant
- Bregma International Trading Company , Ltd.
Saskatoon, Saskatchewan, CA - Received
- February 5, 1999
- Decision date
- July 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K971682 | J-Fx Cerclage SystemLRN · Traditional | Johnson & Johnson Professionals, Inc. | 06/27/1997SE |
| 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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Questions and answers
When was Stainless Steel Soft Suture Wire cleared by the FDA?
Stainless Steel Soft Suture Wire (K990355) received a 510(k) decision of Substantially Equivalent on July 8, 1999, 153 days after the submission was received.
What is the product code of K990355?
The FDA product code is LRN – Wire, Surgical, a Class II (moderate risk) device regulated under 21 CFR 888.3030.