Orthosis, Cranial
Regulation 882.5970
0510(k)s in 12 months (43 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MVA
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthomerica Products, Inc. | 4 | 0 |
| Danmar Products, Inc. | 3 | 0 |
| Invent Medical USA, LLC | 3 | 0 |
| Otto Bock Healthcare LP | 3 | 0 |
| Cranial Technologies, Inc. | 2 | 0 |
| Eastern Cranial Affiliates | 2 | 0 |
| Orthotic & Prosthetic Lab, Inc. | 2 | 0 |
| Advanced Orthopro, Inc. | 1 | 0 |
| Becker Orthopedic Appliance Co. | 1 | 0 |
| Beverly Hills Prosthetics Orthotics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 30, 2024 | K241957 | Talee, Talee PostOp Invent Medical USA, LLC | MVA |
| Jun 22, 2023 | K230444 | Talee, Talee PostOp Invent Medical USA, LLC | MVA |
| Apr 20, 2023 | K223238 | STARband 3D Orthomerica Products, Inc. | MVA |
| Sep 22, 2022 | K220681 | Talee, Talee PostOP Invent Medical USA, LLC | MVA |
| Jul 1, 2022 | K203134 | Hanger Cranial Band 3D Symbion Logistics, LLC | MVA |
| Jun 9, 2022 | K213587 | MyCRO Band Otto Bock Healthcare LP | MVA |
| Jun 7, 2021 | K193383 | SnugKap Headstart, Ltd. | MVA |
| Mar 26, 2021 | K201426 | MyCRO Band Otto Bock Healthcare LP | MVA |
| Oct 16, 2018 | K180568 | KidCap Eastern Cranial Affiliates, LLC | MVA |
| Oct 6, 2014 | K141842 | STARBAND, STARLIGHT Orthomerica Products, Inc. | MVA |
| Jun 6, 2014 | K140353 | STARBAND AND STARLIGHT Orthomerica Products, Inc. | MVA |
| Apr 18, 2014 | K133397 | P-POD P-Pod | MVA |
| Aug 22, 2011 | K111609 | BOSTON BAND Boston Brace Intl., Inc. | MVA |
| Aug 15, 2011 | K111247 | CRANIAL REMOLDING ORTHOSIS Orthotic Care Services, Llp | MVA |
| Apr 18, 2011 | K103362 | AOI CRANIAL HELMET Advanced Orthopro, Inc. | MVA |
| Jan 6, 2010 | K090341 | MICHIGAN CRANIAL RESHAPING ORTHOSIS Danmar Products, Inc. | MVA |
| Sep 10, 2007 | K070694 | CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) Mike Miner | MVA |
| Jul 2, 2007 | K063133 | CRANIAL SOLUTION ORTHOSIS Cranial Solutions | MVA |
| Dec 22, 2006 | K063395 | O&P BIVALVE CRANIAL MOLDING HELMET Orthotic & Prosthetic Lab, Inc. | MVA |
| Dec 17, 2004 | K042385 | DOC BAND-POSTOP Cranial Technologies, Inc. | MVA |
| Sep 9, 2004 | K041215 | CRANIAL HELMET Otto Bock Healthcare LP | MVA |
| Nov 13, 2003 | K021594 | COPC BAND Center For Orthotic and Prosthetic Care,Llc | MVA |
| Oct 31, 2003 | K013452 | DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS Danmar Products, Inc. | MVA |
| Jul 18, 2003 | K030669 | PROVIDENCE MOLDING HELMET Northeast Orthotics and Prothetics, Inc. | MVA |
| Jan 13, 2003 | K023572 | LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET Rehabilitation Institute,Loma Linda University Med | MVA |
| Sep 9, 2002 | K022273 | CRANIAL SYMMETRY SYSTEM Beverly Hills Prosthetics Orthotics, Inc. | MVA |
| Jul 1, 2002 | K021221 | O&P CRANICAL MOLDING HELMET Orthotic & Prosthetic Lab, Inc. | MVA |
| Apr 12, 2002 | K020448 | STATIC CRANIOPLASTY ORTHOSIS Eastern Cranial Affiliates | MVA |
| Feb 5, 2002 | K013719 | BECKER BAND CRANIAL REMOLDING ORTHOSIS Becker Orthopedic Appliance Co. | MVA |
| Feb 5, 2002 | K013700 | ORTHOSIS HELMET MOLDING Precision Prosthetics & Orthotics, Inc. | MVA |
| Jan 17, 2002 | K012804 | PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS Scott E Allen CP | MVA |
| Nov 28, 2001 | K012920 | MOLDED CRANIAL HELMET Fairview Orthopedic Laboratory | MVA |
| Nov 20, 2001 | K012830 | LERMAN & SON CRANIAL ORTHOSIS HELMET Lerman & Son | MVA |
| Oct 29, 2001 | K013458 | CRANIAL HELMET Children'S Hospital | MVA |
| Sep 19, 2001 | K012007 | RHS HELMET Restorative Health Svs, Inc. | MVA |
| Jun 12, 2001 | K011433 | BALLERT CRANIAL MOLDING HELMET Gema, Inc. | MVA |
| Jun 6, 2001 | K003035 | CLARREN HELMET Children'S Hospital & Medical Center | MVA |
| May 29, 2001 | K003630 | DANMAR PRODUCTS MICHIGAN CRANIAL HELMET Danmar Products, Inc. | MVA |
| Apr 25, 2001 | K010273 | CRANIAL MOLDING ORTHOSIS Orthotic Solutions, Inc. | MVA |
| Dec 8, 2000 | K001669 | HANGER CRANIAL BAND Hanger Orthopedic Group, Inc. | MVA |
| Oct 30, 2000 | K000861 | CRANIOCAP Gillette Children'S Specialty Healthcare | MVA |
| Jul 7, 2000 | K001167 | OPI BAND Orthomerica Products, Inc. | MVA |
| May 29, 1998 | DEN980001 | DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND Cranial Technologies, Inc. | MVA |
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