510(k) K994326
- Device
- ASCENT KNEE SYSTEM
- Applicant
- BIOMET MANUFACTURING, INC.
- 510(k) number
- K994326
- Product code
- KWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-07
- Date received
- 1999-12-22
- Regulation
- 888.3720
- Classification name
- Prosthesis, Toe, Constrained, Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TRACY J BICKEL
- Address
- Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 8043792
- 3007366790
- 1450662
- 1226146
- 1825034
- 1649518
- 9613369
- 1423662
- 1834379
- 3010667733
- 3013365802
- 3013176080
- 3022142628
- 3015207155
- 3003477135
- 1020279
- 3035366890
- 1424263
- 2246552
- 3023808054
- 2027754
- 1526534
- 2090040
- 3010220595
- 3017191784
- 3016669046
- 1043534
- 3011580264
- 3009826895
- 3014207283
- 3008749819
- 3007113169
- 2183744
- 3008744062
- 1828288
Source Documents#
Other 510(k) Records For Product Code KWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191966 | NewPrim System | Brm Extremities | 2020-02-13 |
| K190136 | Fusion Silastic System | Fusion Orthopedics, LLC | 2019-10-21 |
| K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018-02-23 |
| K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016-09-08 |
| K102601 | ORTHOFLEX ROD | Ortho-Pro, LLC | 2011-01-14 |
| K023531 | LESSER METATARSAL PHALANGEAL JOINT IMPLANT | Nexa Orthopedics, Inc. | 2003-01-17 |
| K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | 2002-11-26 |
| K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | 2002-11-25 |
| K023562 | MODIFICATION TO CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-11-13 |
| K023086 | CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-10-04 |
| K981194 | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 1998-06-30 |
| K946236 | PROFIX CONFORMING PLUS TIBIAL INSERT | Smith & Nephew Richards, Inc. | 1995-07-06 |
| K943354 | SUTTER HAMMERTOE JOINT PROSTHESIS | Sutter Corp. | 1995-06-12 |
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT | Sgarlato Laboratories, Inc. | 1991-05-29 |
| K884739 | SGARLATO LESSER TOE IMPLANT | Sgarlato Laboratories, Inc. | 1989-05-18 |
Legacy Summary#
summary
FDA Review#
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