510(k) K932041
- Device
- XANCHOR SUTURE ATTACHMENT DEVICE
- Applicant
- ORTHOPAEDIC BIOSYSTEMS
- 510(k) number
- K932041
- Product code
- JDR
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1994-08-12
- Date received
- 1993-04-27
- Regulation
- 888.3030
- Classification name
- Staple, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERRY ZANG
- Address
- 736 N. Country Club Dr. Mesa AZ US 85201 85201
FDA Registration Numbers#
- 3003236702
- 1038671
- 3027071765
- 3020703621
- 3031240334
- 3010462278
- 3007289093
- 3010389204
- 3013011598
- 1649518
- 3005941719
- 3010470577
- 3020899789
- 3009540749
- 3002579136
- 3021336182
- 3014273424
- 3009110133
- 3014302784
- 3032588003
- 2027754
- 3027339877
- 1226544
- 3015440604
- 3027848094
- 2245304
- 1043534
- 3033509898
- 3025603301
- 2320767
- 3011874600
- 3010400367
- 3011580264
- 3005497913
- 3013700547
- 3039081660
- 1828288
- 2650143
- 3034676720
- 3008236846
- 3010331645
- 1721676
- 1526534
- 1833920
- 1219602
- 3010123172
- 3010097171
- 3002949614
- 2028632
- 2530154
- 3027242374
- 1226183
- 1225838
- 3009882462
- 3030183061
- 3004638532
- 3015183635
- 2031009
- 3006017180
- 1833986
- 3010041693
- 8010257
- 3019269298
- 3006638824
- 3011296511
- 3020704423
- 3018094310
- 3021393544
- 1220246
- 3014262693
- 3007503337
- 3026576110
- 3019356409
- 3015542154
- 1720929
- 3013820441
- 3015539532
- 1835296
- 3013365802
- 1219930
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JDR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262451 | Arthrex DynaNite Staples | Arthrex, Inc. | 2026-09-01 |
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026-08-06 |
| K250712 | Linkt Compression Staple System | Trax Surgical | 2025-05-14 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025-04-11 |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025-01-31 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024-09-06 |
| K240212 | COGNiTiON™ Staple System | Ortho Solutions UK , Ltd. | 2024-02-23 |
| K232990 | A’TOMIC™ Nitinol Fixation System | Rmr Ortho, LLC | 2024-01-12 |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | 2023-12-04 |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023-10-19 |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023-08-30 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023-08-28 |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | 2023-08-11 |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023-08-09 |
Legacy Summary#
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FDA Review#
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