Orthosis, Cranial
Neurology · 21 CFR 882.5970
Recent MDR events
13 adverse event reports on file
- OMNIPORE SURGICAL IMPLANTJun 3, 2022InjuryMatrix Surgical Usa3009383407-2022-00001
- LYOPLANT ONLAY 10.0X12.5CMOct 12, 2017MalfunctionAesculap Ag9610612-2017-00491
- LYOPLANT ONLAY 7.5X7.5CMOct 12, 2017MalfunctionAesculap Ag9610612-2017-00494
- CRANIAL PERFORATOR 9/12MM HUDSON SHANKMay 15, 2017MalfunctionAesculap Ag9610612-2017-00267
- CRANIAL REMOLDING HELMETJun 14, 2016OtherKinderbandMW5062898
- DOC CRANIAL BANDING HELMETJun 2, 2015InjuryCranial TechnologiesMW5043010
- P.A.P. PLAGIOCEPHALY APPLIED PRESSURE ORTHOSISSep 22, 2010DeathPersonal Performance Medical Corp.3003603920-2010-00001
- CRANIAL ORTHOTIC STARBAND HELMETSep 1, 2010InjuryOrthomericaMW5017321
- STRYKER CUSTOM CRANIAL IMPLANT KIT - MEDIUMJan 9, 2009OtherMW5009574
- STRYKER CUSTOM CRANIAL IMPLANT KITNov 3, 2008OtherStrkerMW5008886
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
40 firms currently registered for this product code
Orthomerica Products, Inc.
ORLANDO, FL, US
Cranial Technologies, Inc.
Chandler, AZ, US
Abcorp
Boston, MA, US
Abcorp 3d
Columbia, TN, US
Danmar Products, Inc.
ANN ARBOR, MI, US
Surestep, Llc
South Bend, IN, US
Invent Medical Usa, Llc
Warminster, PA, US
Otto Bock Healthcare Lp
Salt Lake City, UT, US
Boston Brace International, Incorporated
Stoughton, MA, US
Invent Medical Usa, Llc
Loveland, CO, US
Headstart Medical
New Westminster British Columbia, CA
Alken, Inc. D/b/a Polhemus
Colchester, VT, US
510(k) clearances
43 clearances for this product code
- Invent Medical USA, LLCAug 30, 2024
K241957 · Talee, Talee PostOp
- Invent Medical USA, LLCJun 22, 2023
K230444 · Talee, Talee PostOp
- Orthomerica Products, Inc.Apr 20, 2023
K223238 · STARband 3D
- Invent Medical USA, LLCSep 22, 2022
K220681 · Talee, Talee PostOP
- Symbion Logistics, LLCJul 1, 2022
K203134 · Hanger Cranial Band 3D
- Otto Bock Healthcare LPJun 9, 2022
K213587 · MyCRO Band
- Headstart, Ltd.Jun 7, 2021
K193383 · SnugKap
- Otto Bock Healthcare LPMar 26, 2021
K201426 · MyCRO Band