Plate, Cranioplasty, Preformed, Non-Alterable
TI Cranial Flap Tube Clamp Textured 22MM DIA-Sterile
3manufacturers in China registered for this device type
263catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | GXN |
| Device type | Plate, Cranioplasty, Preformed, Non-Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5330 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K033868 |
| Record published | 2015-09-14 |
| Record revised | 2025-06-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD420.421 | In distribution | |
| SD420.526 | In distribution | |
| SD420.437 | In distribution | |
| SD420.523 | In distribution | |
| SD800.454 | In distribution | |
| SD420.430 | In distribution | |
| SD800.449 | In distribution | |
| SD800.544 | In distribution | |
| SD420.503 | In distribution | |
| SD800.562 | In distribution | |
| SD800.522 | In distribution | |
| SD800.507 | In distribution | |
| SD420.417 | In distribution | |
| SD800.434 | In distribution | |
| SD800.506 | In distribution | |
| SD420.506 | In distribution | |
| SD420.438 | In distribution | |
| SD800.517 | In distribution | |
| SD800.565 | In distribution | |
| 460.100 | In distribution | |
| SD800.467 | In distribution | |
| SD800.432 | In distribution | |
| SD800.455 | In distribution | |
| SD420.532 | In distribution | |
| SD800.569 | In distribution | |
| SD800.458 | In distribution | |
| SD420.433 | In distribution | |
| SD420.518 | In distribution | |
| SD420.452 | In distribution | |
| SD420.402 | In distribution | |
| SD800.510 | In distribution | |
| SD800.410 | In distribution | |
| SD420.536 | In distribution | |
| SD800.563 | In distribution | |
| SD800.422 | In distribution | |
| SD800.525 | In distribution | |
| 488.066 | In distribution | |
| SD800.452 | In distribution | |
| SD800.469 | In distribution | |
| 460.002 | In distribution | |
| SD420.414 | In distribution | |
| SD800.556 | In distribution | |
| SD800.406 | In distribution | |
| SD800.512 | In distribution | |
| SD800.545 | In distribution | |
| SD800.561 | In distribution | |
| SD420.401 | In distribution | |
| SD800.405 | In distribution | |
| SD420.538 | In distribution | |
| SD800.541 | In distribution | |
| SD420.507 | In distribution | |
| SD800.402 | In distribution | |
| SD420.405 | In distribution | |
| SD800.447 | In distribution | |
| SD420.513 | In distribution | |
| SD800.423 | In distribution | |
| SD800.542 | In distribution | |
| SD800.448 | In distribution | |
| SD800.531 | In distribution | |
| SD800.526 | In distribution | |
| SD800.470 | In distribution | |
| SD420.431 | In distribution | |
| 460.008 | In distribution | |
| SD800.430 | In distribution | |
| SD420.527 | In distribution | |
| SD800.463 | In distribution | |
| SD800.551 | In distribution | |
| SD420.429 | In distribution | |
| SD420.428 | In distribution | |
| SD800.420 | In distribution | |
| SD800.536 | In distribution | |
| 460.001.01S | In distribution | |
| SD800.535 | In distribution | |
| SD420.502 | In distribution | |
| SD800.516 | In distribution | |
| SD800.424 | In distribution | |
| SD420.448 | In distribution | |
| SD800.426 | In distribution | |
| SD420.534 | In distribution | |
| SD800.428 | In distribution | |
| SD800.567 | In distribution | |
| SD800.460 | In distribution | |
| SD800.568 | In distribution | |
| SD420.546 | In distribution | |
| SD420.404 | In distribution | |
| SD800.444 | In distribution | |
| SD800.511 | In distribution | |
| SD800.404 | In distribution | |
| SD420.418 | In distribution | |
| SD800.421 | In distribution | |
| SD800.558 | In distribution | |
| SD800.553 | In distribution | |
| SD800.450 | In distribution | |
| SD420.432 | In distribution | |
| SD420.407 | In distribution | |
| SD800.504 | In distribution | |
| SD420.411 | In distribution | |
| SD420.425 | In distribution | |
| SD420.531 | In distribution | |
| SD800.501 | In distribution | |
| 460.003 | In distribution | |
| SD420.444 | In distribution | |
| SD800.401 | In distribution | |
| SD800.566 | In distribution | |
| SD800.539 | In distribution | |
| SD800.431 | In distribution | |
| SD800.515 | In distribution | |
| SD800.546 | In distribution | |
| SD420.443 | In distribution | |
| SD800.433 | In distribution | |
| SD800.435 | In distribution | |
| SD800.407 | In distribution | |
| SD420.543 | In distribution | |
| SD800.564 | In distribution | |
| SD800.509 | In distribution | |
| SD420.521 | In distribution | |
| SD800.560 | In distribution | |
| SD420.453 | In distribution | |
| 460.107 | In distribution | |
| SD800.559 | In distribution | |
| SD800.416 | In distribution | |
| SD420.440 | In distribution | |
| SD800.524 | In distribution | |
| 460.003.01S | In distribution | |
| SD800.529 | In distribution | |
| SD800.412 | In distribution | |
| SD800.436 | In distribution | |
| SD420.420 | In distribution | |
| SD800.446 | In distribution | |
| SD800.411 | In distribution | |
| SD420.505 | In distribution | |
| 460.010.01S | In distribution | |
| SD420.419 | In distribution | |
| SD800.425 | In distribution | |
| 460.001 | In distribution | |
| SD800.530 | In distribution | |
| SD800.514 | In distribution | |
| SD420.441 | In distribution | |
| SD800.537 | In distribution | |
| SD420.552 | In distribution | |
| SD800.456 | In distribution | |
| SD420.533 | In distribution | |
| SD800.440 | In distribution | |
| SD800.427 | In distribution | |
| SD420.412 | In distribution | |
| SD800.414 | In distribution | |
| SD800.533 | In distribution | |
| SD420.436 | In distribution | |
| SD800.457 | In distribution | |
| SD800.409 | In distribution | |
| SD420.442 | In distribution | |
| SD800.528 | In distribution | |
| SD420.450 | In distribution | |
| SD420.446 | In distribution | |
| SD420.539 | In distribution | |
| SD800.465 | In distribution | |
| SD420.509 | In distribution | |
| SD420.439 | In distribution | |
| SD420.422 | In distribution | |
| SD420.551 | In distribution | |
| SD420.504 | In distribution | |
| SD420.542 | In distribution | |
| SD420.525 | In distribution | |
| SD800.532 | In distribution | |
| SD420.508 | In distribution | |
| 460.009.01S | In distribution | |
| SD420.427 | In distribution | |
| SD800.543 | In distribution | |
| 460.107.01S | In distribution | |
| SD800.505 | In distribution | |
| SD420.520 | In distribution | |
| SD800.540 | In distribution | |
| SD420.435 | In distribution | |
| SD420.549 | In distribution | |
| SD800.403 | In distribution | |
| SD800.538 | In distribution | |
| SD800.466 | In distribution | |
| SD420.550 | In distribution | |
| SD420.426 | In distribution | |
| SD800.557 | In distribution | |
| SD420.540 | In distribution | |
| SD420.519 | In distribution | |
| SD420.449 | In distribution | |
| SD420.447 | In distribution | |
| 460.100.01S | In distribution | |
| SD800.550 | In distribution | |
| SD420.424 | In distribution | |
| SD420.545 | In distribution | |
| SD420.445 | In distribution | |
| SD800.441 | In distribution | |
| SD420.537 | In distribution | |
| 460.010 | In distribution | |
| SD420.434 | In distribution | |
| SD420.524 | In distribution | |
| SD420.451 | In distribution | |
| SD420.535 | In distribution | |
| SD420.547 | In distribution | |
| 460.002.01S | In distribution | |
| SD420.548 | In distribution | |
| SD420.415 | In distribution | |
| SD800.429 | In distribution | |
| SD800.534 | In distribution | |
| SD800.408 | In distribution | |
| SD420.517 | In distribution | |
| SD420.516 | In distribution | |
| SD420.541 | In distribution | |
| SD420.511 | In distribution | |
| SD420.408 | In distribution | |
| SD800.468 | In distribution | |
| SD420.544 | In distribution | |
| SD800.461 | In distribution | |
| SD800.464 | In distribution | |
| SD800.555 | In distribution | |
| SD420.522 | In distribution | |
| SD800.549 | In distribution | |
| SD800.415 | In distribution | |
| SD800.521 | In distribution | |
| SD800.554 | In distribution | |
| SD800.417 | In distribution | |
| SD800.523 | In distribution | |
| SD420.416 | In distribution | |
| SD800.462 | In distribution | |
| SD800.520 | In distribution | |
| SD800.508 | In distribution | |
| 460.009 | In distribution | |
| SD800.413 | In distribution | |
| SD800.519 | In distribution | |
| SD420.528 | In distribution | |
| SD800.513 | In distribution | |
| SD420.409 | In distribution | |
| SD420.512 | In distribution | |
| SD800.527 | In distribution | |
| SD800.438 | In distribution | |
| SD800.419 | In distribution | |
| SD800.451 | In distribution | |
| SD420.410 | In distribution | |
| SD420.529 | In distribution | |
| 460.008.01S | In distribution | |
| SD800.442 | In distribution | |
| SD420.515 | In distribution | |
| SD800.502 | In distribution | |
| SD800.437 | In distribution | |
| SD420.514 | In distribution | |
| SD800.548 | In distribution | |
| SD800.439 | In distribution | |
| SD420.553 | In distribution | |
| SD800.443 | In distribution | |
| SD800.552 | In distribution | |
| SD420.406 | In distribution | |
| SD420.510 | In distribution |
Showing 250 of 263 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HTR-Pekk | Oxford Performance Materials, Inc. | 4,551 |
| Kelyniam CSI | Kelyniam Global Inc. | 1,714 |
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour (Xi’an) Medical Technology Co., Ltd. | 162 |
| CranioFit | Bioplate, Inc. | 161 |
| IPS | KLS-Martin L.P. | 74 |
| AccuShape | MedCAD | 27 |
| ClearFit | Longeviti Neuro Solutions | 26 |
| IPS, Sterile | KLS-Martin L.P. | 18 |
| Level ONE Thoracic, Sterile | KLS-Martin L.P. | 14 |
| Meticuly Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 13 |
| Bioplate® | Bioplate, Inc. | 13 |
| Invisx™ | Medtronic PS Medical | 12 |
Showing 12 of 32. All products under Plate, Cranioplasty, Preformed, Non-Alterable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243715 | 2025-11-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2015-08-31 | Class II | Labeling False and Misleading | The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe. | 105882 | 2016-08-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.