Non-Absorbing Sternatomy Monofilament Suture
FDA 510(k) K002755 · T. Korossurgical Instruments Corp.
510(k) numberK002755
Submission
- Device name
- Non-Absorbing Sternatomy Monofilament Suture
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- September 5, 2000
- Decision date
- December 4, 2000
- 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 |
|---|---|---|---|
| K990355 | Stainless Steel Soft Suture WireLRN · Traditional | Bregma International Trading Company , Ltd. | 07/08/1999SE |
| 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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| K953998 | Discetome Tissue AspiratorHRX · Traditional | 12/04/1995SE |
| K954052 | Arthroscopic Grasper, Cup Forceps and CurettesHRX · Traditional | 11/06/1995SN |
| K954014 | Percutaneous Discectomy Cannula SystemHRX · Traditional | 11/06/1995SN |
| K935529 | Cervical Self-Retaining RetractorGZT · Traditional | 03/22/1994SE |
| K931262 | Reusable/Interchangeable Shaft, Endoscopic ScissorGCJ · Traditional | 08/06/1993SE |
| K926585 | Thorocoscopy Self-Retaining RetractorGAD · Traditional | 08/06/1993SE |
| K926583 | Reusable Endoscopic Scissors, Grasper-MonopolarGCJ · Traditional | 08/06/1993SE |
| K931259 | Endoscopic or Thorascopic ForcepsGCJ · Traditional | 06/08/1993SE |
Questions and answers
When was Non-Absorbing Sternatomy Monofilament Suture cleared by the FDA?
Non-Absorbing Sternatomy Monofilament Suture (K002755) received a 510(k) decision of Substantially Equivalent on December 4, 2000, 90 days after the submission was received.
What is the product code of K002755?
The FDA product code is LRN – Wire, Surgical, a Class II (moderate risk) device regulated under 21 CFR 888.3030.